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Mitsubishi Shipbuilding and INPEX Complete Conceptual Study for Ammonia Bunkering Vessel

TOKYO, Feb 2, 2023 - (JCN Newswire via SEAPRWire.com) - Mitsubishi Shipbuilding Co., Ltd., a Mitsubishi Heavy Industries (MHI) Group company based in Yokohama, has recently completed a conceptual study for an ammonia bunkering vessel capable of supplying ammonia fuel to ships. This study involved joint investigations with INPEX CORPORATION, which boasts abundant achievements and experience in the energy supply chain, in order to respond to increasing demands for ammonia-fueled ships.Image of Ammonia Bunkering VesselSince ammonia does not emit carbon dioxide (CO2) when burned, it is expected to be utilized as a stable source of clean energy in the future, and is getting attention as a fuel that will greatly contribute to the reduction of greenhouse gas emissions in the maritime industry. Mitsubishi Shipbuilding has made use of its ample knowledge of the design and production of multi-purpose liquefied gas carriers, which are capable of transporting ammonia, in furthering conceptual considerations for a highly flexible ammonia bunkering vessel having enough tank capacity, ship maneuverability, and bunkering equipment that ensures compatibility with various ammonia-fueled vessels expected to be served.Based on the knowledge and technical tasks acquired in this study, Mitsubishi Shipbuilding will carry out further technical investigations, and with the cooperation of the maritime-related companies involved and the like, will set its sights on the commercialization of this vessel. Moreover, in order to contribute to customer needs in terms of the whole value chain, Mitsubishi Shipbuilding will continue to put efforts into developing various types of ships.Mitsubishi Shipbuilding is an integral part of MHI Group's Energy Transition strategy. As a maritime system integrator, Mitsubishi Shipbuilding will continue to focus on developing and commercializing not only ammonia bunkering vessels, but alternative fuel vessels and relevant equipment in order to realize a carbon neutral society.About MHI GroupMitsubishi Heavy Industries (MHI) Group is one of the world's leading industrial groups, spanning energy, smart infrastructure, industrial machinery, aerospace and defense. MHI Group combines cutting-edge technology with deep experience to deliver innovative, integrated solutions that help to realize a carbon neutral world, improve the quality of life and ensure a safer world. For more information, please visit www.mhi.com or follow our insights and stories on spectra.mhi.com. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

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Lecanemab Receives Priority Review Status in Japan

TOKYO and CAMBRIDGE, Mass., Jan 30, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that an application for manufacturing and marketing approval for lecanemab (generic name, U.S. brand name: LEQEMBI), an anti-amyloid-beta (Abeta) protofibril* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare (MHLW). Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened. In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds and eliminates soluble, toxic Abeta aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal. In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023 and accepted on January 26, 2023. In China, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) in December 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. *Protofibrils are large Abeta aggregated soluble species of 75-500 Kd. (1),(2)For more information, visit www.eisai.com/news/2023/news202312.html. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

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Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer’s Disease in Japan

TOKYO and CAMBRIDGE, Mass., Jan 16, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril(1) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA).This application is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab. In the Clarity AD study, lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale as the primary endpoint (CDR-SB(2): Clinical Dementia Rating-Sum of Boxes) as early as six months, and over time across all time points. All key secondary endpoints also showed highly statistically significant results. Especially, treatment with lecanemab showed a statistically significant reduction in amyloid plaque burden at all timepoints starting at 3 months in the amyloid PET study and statistically significantly slowed decline of activities of daily living on ADCS MCI-ADL(3). The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.In November 2022, the results of Clarity AD study were presented at the 15th Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal the New England Journal of Medicine(New Window).In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023. In China, Eisai initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully gain health authority approval.For more information, visit www.eisai.com/news/2023/news202307.html.MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL: +81-(0)3-3817-5120Eisai Inc. (U.S.)Libby Holman+ 1-201-753-1945Libby_Holman@eisai.com INVESTOR CONTACT:Eisai Co., Ltd.Investor Relations DepartmentTEL: +81-(0)03-3817-5122 Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

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Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe

TOKYO, Jan 11, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) to the European Medicines Agency (EMA). This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD, and is subject to a validation to determine whether the EMA accepts the application for review.The Clarity AD study met its primary endpoint (CDR-SB(1): Clinical Dementia Rating-Sum of Boxes) and all key secondary endpoints with highly statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, peer-reviewed medical journals.In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day. In China, Eisai has initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022. In Japan, Eisai plans to submit a marketing authorization application by the end of Eisai's fiscal year 2022, which ends March 31, 2023.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.(1) CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia. Based on interviews of people living with AD and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and CDR-SB is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of AD.Media Contacts:Eisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120Eisai Europe, Ltd.(Europe, Australia, New Zealand and Russia)EMEA Communications Department+44 (0) 786 601 1272EMEA-comms@eisai.netBiogen Inc.Natacha Gassenbach+ 1-857-777-6573public.affairs@biogen.comInvestor Contacts: Eisai Co., Ltd. Investor Relations DepartmentTEL: +81 (0) 3-3817-5122Biogen Inc.Mike Hencke+ 1-781-464-2442IR@biogen.com Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

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HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations

ROCKVILLE, MD and SHENZHEN, CHINA, Jan 5, 2023 - (ACN Newswire via SEAPRWire.com) - HighTide Therapeutics Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the closing of a $107 million Series C/C+ financing led by the TCM Healthcare Fund of Guangdong, managed by China Development Bank Capital. Other investors included Yuexiu Fund and Yuthai Fund. Proceeds of the financing will be used to advance multiple global development programs, including mid-to-late-stage clinical trials, and the commercialization and business development of the company's robust pipeline. HighTide's lead candidate HTD1801, is a novel multifunctional molecule, being developed for the treatment of patients suffering from complex metabolic and digestive diseases. HighTide has successfully completed multiple clinical trials of HTD1801 and continues to advance its global development programs as follows:-- A Phase 2 clinical study in type 2 diabetes (T2DM) is near completion;-- A Phase 2b clinical study in nonalcoholic steatohepatitis (NASH) has been initiated; and -- A successful End-of-Phase 2 (EOP2) meeting was held with the U.S. Food and Drug Administration (FDA) based on the positive findings from the Phase 2 clinical study in primary sclerosing cholangitis (PSC)."After completing a successful $60 million Series B+ round at the end of 2020, we are thrilled to have well-recognized investors participate in our C/C+ round. We are grateful that our investors have such strong confidence in HighTide's team, the commercial value of our pipeline, and future development prospects," said Liping Liu, Ph.D., founder and Chief Executive Officer of HighTide. "The Series C/C+ financing is a significant milestone for HighTide. It will enable us to move aggressively to accelerate the clinical and commercial development of our innovative pipeline and external business collaborations."About HighTide TherapeuticsHighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). The U.S. Food and Drug Administration (FDA) granted Fast Track designation to HTD1801 for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.Contacts:InvestorsNadia Gaoir@hightidetx.com+86-134-8219-0265MediaKarl Schmiederkarl@messaginglab.com+1-646-515-3392 Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)

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MHI Signs MoU with Chile’s Guacolda Energia for Feasibility Study of Ammonia Co-Firing at a Coal-Fired Thermal Power Plant

TOKYO, Dec 7, 2022 - (JCN Newswire via SEAPRWire.com) - Mitsubishi Heavy Industries, Ltd. (MHI), on December 6, signed a Memorandum of Understanding (MoU) with Guacolda Energia SpA, an independent power producer (IPP) in the Republic of Chile, to begin a feasibility study for the introduction of ammonia co-firing at a coal-fired thermal power plant operated by the company in the north of the country. The project is being undertaken in response to the global trend toward reducing CO2 emissions.Signing CeremonyThe signing ceremony was held at the Nagasaki Shipyard & Machinery Works in Japan, the base for MHI;s steam power plant business. The executive team from Guacolda was led by Chairman Jorge Rodriguez, with MHI represented by Masahiko Hokano, Head of the Steam Power Maintenance Innovation (SPMI) Business Division.The power plant that will be the site of the study is located in Huasco, Atacama Region, approximately 700 km north of the capital city of Santiago. The plant comprises five power generation units with a total output of 758 megawatts (MW). MHI supplied the boiler, steam turbine, and other core facilities for this plant.Under the feasibility study plan based on the MoU, MHI, with support from its power solutions brand Mitsubishi Power, will determine and conduct a study of supplying the ammonia burners and other boiler facilities and equipment necessary for ammonia co-firing. Phase 1, through 2024, will be a basic study for 30% ammonia co-firing to identify the problems involved. Phase 2, from 2025 to 2026, will be to consider solutions to the problems identified in Phase 1, and compile a detailed plan for demonstration of 30% ammonia co-firing. In the future, Guacolda aims to conduct demonstration testing at the plant and increase the co-firing rate.Chile has set a target for carbon neutrality by 2050 and plans to increasingly incorporate non-conventional renewable energy sources into the Chilean electricity matrix. As a country with abundant renewable energy resources, Chile is considered to have high potential as a producer of green ammonia, and Guacolda is looking to ammonia co-firing as a means of cutting CO2 emissions and reducing its environmental load in order to maintain operations at its power plant. MHI's position as the supplier of the core facilities of this power plant, and a leader in ammonia co-firing technologies, led to the conclusion of this MoU.Commenting on the signing of the MoU, Guacolda Chairman Jorge Rodriguez said: "A rational policy to reduce greenhouse gases should consider a gradual withdrawal from the use of fossil fuels, combining them with more climate-friendly energies such as green hydrogen, green ammonia and long-term storage technologies, in the most economical way possible but always safeguard the safety of the electrical system as a whole."Masahiko Hokano, Head of the SPMI Business Division at MHI said: "We are very honored to be able to proceed with this feasibility study on ammonia co-firing in Chile, which is highly proactive in decarbonization efforts and has great expectations from the world in terms of renewable energy and clean fuel derived from it. By combining MHI's innovative ammonia co-firing technology with Guacolda's deep technical knowledge and power plant management know-how, we are confident that we can contribute to the further acceleration of decarbonization in Guacolda, and consequently in Chile."Going forward, building on the conclusion of this MoU, MHI will work offer the solutions for decarbonization and improved performance needed by IPPs and the entire power generation industry around the world, and will make a concerted effort to successfully complete this feasibility study, contributing to the stable supply of energy and the reducing of environmental loads.About MHI GroupMitsubishi Heavy Industries (MHI) Group is one of the world's leading industrial groups, spanning energy, smart infrastructure, industrial machinery, aerospace and defense. MHI Group combines cutting-edge technology with deep experience to deliver innovative, integrated solutions that help to realize a carbon neutral world, improve the quality of life and ensure a safer world. For more information, please visit www.mhi.com or follow our insights and stories on spectra.mhi.com. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference

TOKYO, Nov 30, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, in San Francisco, California and virtually.Figure 1: CDR-SB as Primary endpoint change (18 months)Summary of Presentations in the Scientific Session featuring Lecanemab at CTADDesign of Clarity AD StudyEisai's Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia. The participants were randomized 1:1 to receive either placebo or lecanemab 10-mg/kg IV biweekly, and the randomization was stratified according to clinical subgroup (MCI due to AD or mild AD), presence or absence of concomitant approved AD symptomatic medication at baseline (e.g., acetylcholinesterase inhibitors, memantine, or both), ApoE4 status and geographical region. Eligibility criteria allowed patients with a broad range of comorbidities/comedications, including but not limited to hypertension, diabetes, heart disease, obesity, renal disease and anti-coagulants. As a result of Eisai's recruitment strategy of diversity in the Clarity AD study, 4.5% and 22.5% of the randomized participants in the U.S. were Black and Hispanic, respectively.The primary endpoint was change from baseline at 18 months in the CDR-SB1 (Clinical Dementia Rating Sum of Boxes), the global cognitive and functional scale, and key secondary endpoints were the change from baseline at 18 months in amyloid Positron Emission Tomography (PET) using Centiloids, AD Assessment Scale - Cognitive Subscale 14 (ADAS-Cog142), AD Composite Score (ADCOMS3) and AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL4). In addition, longitudinal changes in brain tau pathology as measured by tau PET (n=257) and cerebrospinal fluid (CSF) biomarkers of AD pathology (n=281) were evaluated in optional sub-studies.Efficacy Results of Clarity ADMean change of CDR-SB from baseline at 18 months as the primary endpoint was 1.21 and 1.66 for lecanemab and placebo groups, respectively. Lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale, compared with placebo at 18 months by -0.45 (95% Confidence Interval (CI): -0.67, -0.23; P=0.00005), representing a 27% slowing of decline. Starting as early as six months (difference: -0.17 [95% CI: -0.29, -0.05]; PAll key secondary endpoints also showed highly statistically significant results compared with placebo (PFor more information, visit www.eisai.com/news/2022/pdf/enews202285pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Eleven Experts from Leading Medical Institutions and Eight Experts from Eisai Publish Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease in the New England Journal of Medicine

TOKYO, Nov 30, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, were published in the New England Journal of Medicine, one of the world's most prestigious peer-reviewed medical journals. For the details of the paper, please refer to: www.nejm.org/doi/full/10.1056/NEJMoa2212948.The rapid publication of the Clarity AD study results demonstrates Eisai's strong commitment to trust and transparency based on Eisai's human health care mission. Eisai and Biogen remain committed to disclosing data and information on lecanemab. If approved, we will work to bring the drug expeditiously to people living with early AD and their families.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully gain health authority approval.For more information, visit www.eisai.com/news/2022/pdf/enews202284pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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AJG Publishes Data from HighTide Therapeutics’ Phase 2 Study of HTD1801 Treatment in Primary Sclerosing Cholangitis

ROCKVILLE, MD and SHENZHEN, CHINA, Nov 17, 2022 - (ACN Newswire via SEAPRWire.com) - HighTide Therapeutics, Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the publication of the results of their Phase 2 study of HTD1801 in adults with primary sclerosing cholangitis (PSC) in the American Journal of Gastroenterology. (https://journals.lww.com/ajg/Fulltext/2022/11000/A_Randomized,_Dose_Finding,_Proof_of_Concept_Study.22.aspx)This study met the primary endpoint and multiple key secondary endpoints, demonstrating the safety and efficacy of HTD1801 in treating PSC. Serum alkaline phosphatase (ALP) is a key biomarker of PSC disease severity. Data show that compared to placebo, both low and high doses of HTD1801 treatment could significantly reduce serum ALP levels. In addition, HTD1801 significantly reduced alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT), further supporting the beneficial effects of HTD1801 in treating PSC. HTD1801 was shown to be safe and well tolerated at the doses studied in PSC patients. No severe adverse event related to HTD1801 treatment occurred.Professor Kris Kowdley, M.D., Director, Liver Institute Northwest and lead investigator, said, "There is a significant unmet medical need in treatment for PSC. The improvements in ALP we observed in this study, along with the excellent safety profile of HTD1801, are promising. In addition, the results of this study lay the foundation for future studies that will potentially prove the significant role of HTD1801 in the treatment of PSC."Dr. Liping Liu, Founder and Chief Executive Officer of HighTide Therapeutics, said, "We are pleased to share the news of this publication. The results of this study encourage us to further study HTD1801's effects in treating PSC. We believe the long-term treatment of HTD1801 will lead to more clinical benefits for patients with PSC, who suffer with a disease with no effective therapy until today."About Primary Sclerosing CholangitisPrimary sclerosing cholangitis (PSC) is a chronic, progressive liver disease characterized by progressive inflammation and fibrosis of the intra-and/or extra-hepatic bile ducts, resulting in multifocal bile duct strictures. Most patients eventually have liver failure and cirrhosis, and their risk of malignancy significantly increases. PSC is strongly associated with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The accumulating evidence from various studies continues to strengthen the hypothesis that the gut microbiota plays a central role in the pathogenesis and progression of PSC. Until today, there is no approved therapy for PSC. As the fifth leading indication for liver transplantation in the U.S., PSC is a disease with significant unmet medical needs.About HighTide TherapeuticsHighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). HTD1801 has received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.ContactJeffrey Daoir@hightidetx.com+1-650-580-3872 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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American Journal of Gastroenterology Publishes Data from HighTide Therapeutics’ Phase 2 Study of HTD1801 Treatment in Primary Sclerosing Cholangitis

ROCKVILLE, MD and SHENZHEN, CHINA, Nov 16, 2022 - (ACN Newswire via SEAPRWire.com) - HighTide Therapeutics, Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the publication of the results of their Phase 2 study of HTD1801 in adults with primary sclerosing cholangitis (PSC) in the American Journal of Gastroenterology.This study met the primary endpoint and multiple key secondary endpoints, demonstrating the safety and efficacy of HTD1801 in treating PSC. Serum alkaline phosphatase (ALP) is a key biomarker of PSC disease severity. Data show that compared to placebo, both low and high doses of HTD1801 treatment could significantly reduce serum ALP levels. In addition, HTD1801 significantly reduced alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT), further supporting the beneficial effects of HTD1801 in treating PSC. HTD1801 was shown to be safe and well tolerated at the doses studied in PSC patients. No severe adverse event related to HTD1801 treatment occurred.Professor Kris Kowdley, M.D., Director, Liver Institute Northwest and lead investigator, said, "There is a significant unmet medical need in treatment for PSC. The improvements in ALP we observed in this study, along with the excellent safety profile of HTD1801, are promising. In addition, the results of this study lay the foundation for future studies that will potentially prove the significant role of HTD1801 in the treatment of PSC."Dr. Liping Liu, Founder and Chief Executive Officer of HighTide Therapeutics, said, "We are pleased to share the news of this publication. The results of this study encourage us to further study HTD1801's effects in treating PSC. We believe the long-term treatment of HTD1801 will lead to more clinical benefits for patients with PSC, who suffer with a disease with no effective therapy until today."About Primary Sclerosing CholangitisPrimary sclerosing cholangitis (PSC) is a chronic, progressive liver disease characterized by progressive inflammation and fibrosis of the intra-and/or extra-hepatic bile ducts, resulting in multifocal bile duct strictures. Most patients eventually have liver failure and cirrhosis, and their risk of malignancy significantly increases. PSC is strongly associated with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The accumulating evidence from various studies continues to strengthen the hypothesis that the gut microbiota plays a central role in the pathogenesis and progression of PSC. Until today, there is no approved therapy for PSC. As the fifth leading indication for liver transplantation in the U.S., PSC is a disease with significant unmet medical needs.About HighTide TherapeuticsHighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). HTD1801 has received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.ContactJeffrey Daoir@hightidetx.com+1-650-580-3872American Journal of Gastroenterologyhttps://tinyurl.com/mr3wyhu6 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Eisai Satisfies All-case Study Requirement for Antiepileptic Agent Inovelon

TOKYO, Nov 2, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that it has received notification from Japan's Ministry of Health, Labour, and Welfare (MHLW) that the "all-case study" specified post-marketing observational study condition required at the time of approval of antiepileptic agent Inovelon Tablets 100 mg and 200 mg (rufinamide) as an adjunctive therapy to other antiepileptic drugs (AEDs) for treatment of Lennox-Gastaut syndrome (LGS) has been cleared. In March 2013, the MHLW approved Inovelon as an adjunctive therapy with other antiepileptic drugs for tonic and atonic seizures associated with LGS showing insufficient response to other antiepileptics, with the following condition: "Because of the very limited number of subjects included in the Japanese clinical trials, the applicant is required to conduct a post-marketing observational study in all patients until data from a certain number of patients is accumulated after its launch in the market, in order to identify the background information of patients treated with the product and collect safety and efficacy data on the product in the early post-marketing period, and thereby take necessary measures to ensure proper use of the product." Based on the safety data in 702 patients and efficacy data in 495 patients submitted to the MHLW as the results of analyses of this all-case study, the MHLW has concluded that the all-case study was conducted properly and the necessary measures to ensure proper use of the product were sufficient to lift the condition. Eisai will continually strive to promote the proper use of Inovelon and provide information about the product, thereby making further contributions to increase the benefits to patients and their families.For more information, visit www.eisai.com/news/2022/news202275.html.Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Eisai Announces Plans to Submit Application for Partial Change to Label for Dosage and Administration of Aricept for Treatment of Dementia with Lewy Bodies Based on Results of Drug Reexamination

TOKYO, Nov 2, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that it has received notification that Aricept (donepezil hydrochloride), a treatment for Alzheimer's disease and dementia with Lewy bodies that was discovered and developed in-house, has been granted Category 2* status based on the results of a reexamination of its efficacy, dosage and administration for the treatment of dementia with Lewy bodies (DLB) in Japan. In conjunction with this, Eisai plans to promptly submit an application for a partial change to label regarding dosage and administration. The indication for DLB remains unchanged. The indication of "suppression of progression of dementia symptoms in DLB" was approved in September 2014, primarily based on a Phase II study (Study 431) and Phase III study (Study 341) conducted by Eisai on people living with DLB in Japan. In accordance with the condition for the approval of this indication, "a clinical trial to verify the efficacy and safety of the drug in patients with DLB should be conducted and the results of the trials and analyses should be submitted promptly after completion," Eisai conducted a post-marketing clinical study (Study 419) to evaluate the efficacy and safety of the drug in patients with DLB. The results of Study 419 did not show a statistically significant difference between the placebo group and the Aricept group in the primary endpoint of global function (CIBIC-plus** comprehensive assessment), but the re-examination based on post-marketing studies, including the results of Study 419, stated that "at present, the evaluation of clinical function in DLB using CIBIC-Plus is not always sufficiently established as an evaluation method, and it is difficult to comprehensively evaluate the efficacy of this drug for DLB, although efficacy was seen in some patients. On the other hand, treatment with this drug showed a trend toward improvement in cognitive function (MMSE***), and this result is consistent with the results of the clinical trial at the time of approval of the drug. Since there are a certain number of patients who can be expected to benefit from the administration of this drug, it was concluded that the efficacy should be evaluated after the start of administration, and administration should only continue if efficacy is confirmed."Therefore, it was concluded that the approved label (dose and administration) and package insert should be appropriately revised (Category 2).The condition of the approval was lifted as of the date of receipt of the reexamination results. Along with this prompt application for a partial change to label regarding dosage and administration for the DLB indication, Eisai will place the highest priority on the provision of proper use and safety information for this drug, and will make continued contributions to address the diversified needs of, and increase the benefits provided to people living with DLB and their families. For more information, visit www.eisai.com/news/2022/news202274.html. Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Sinomab Announces IND Application of SN1011 for the Treatment of Neuromyelitis Optica Spectrum Disorder Approved by NMPA

HONG KONG, Aug 24, 2022 - (ACN Newswire via SEAPRWire.com) - SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 23 August 2022, an Investigational New Drug application ("IND", for neuromyelitis optica spectrum disorder ("NMOSD")) for SN1011 was approved by the National Medical Products Administration of China (the "NMPA"). The IND approval would enable the Company to initiate the Phase II/III clinical study in China to evaluate the efficacy and safety of SN1011 for the treatment of NMOSD in China. The planned first patient enrollment is in the first quarter of 2023.SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy, and improved safety for the long-term treatment of systemic lupus erythematous ("SLE"), pemphigus ("PV"), multiple sclerosis ("MS"), neuromyelitis optica spectrum disorder("NMOSD") and other rheumatoid or immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety. The Phase I study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated good safety and pharmacokinetics profile. Currently, four IND applications of SN1011 for the treatment of SLE, PV, MS and NMOSD have been approved by NMPA respectively. At the same time, the Company is planning an IND submission for MS in the U.S.NMOSD is an autoimmune-mediated inflammatory demyelinating disease of the central nervous system with predominant involvement of the optic nerve and spinal cord. The pathogenesis of NMOSD is mainly associated with aquaporin-4 (AQP4) antibodies and is a separate disease entity from multiple sclerosis, with severe optic neuritis and longitudinal extensive transverse myelitis as the main clinical features. However, the cause of NMOSD is unknown, with a combination of environmental factors such as smoking, low vitamin D levels, EBV infection and genetic susceptibility contributing to the development of the disease. Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "The IND application of SN1011 for the treatment of NMOSD was accepted by the NMPA at the beginning of June, and approved within three months, fully reflecting the potential of SN1011 as well as the efficient execution of the Company's new drug R&D program. The clinical study for the treatment of NMOSD is the fourth indication of SN1011 approved in China following the approval of IND application for SLE, PV and MS, fully demonstrating the great potential of the innovative BTK inhibitor towards multiple indications in the field of the treatment of autoimmune diseases. Currently, numerous of Company's main candidate products, covering indications in the field of autoimmune diseases, have entered clinical stage gradually. Among which, our flagship product SM03 (Suciraslimab) is approaching the endpoint in its Phase III clinical study for rheumatoid arthritis. As the clinical studies of our key candidates moving forward, we will continue to expand the potential indications of the products, promote the global R&D progress and constantly improve our production facility and expand capacity to enhance our commercialization capability. SinoMab is devoting to becoming a biopharmaceutical company, with R&D headquartered in Hong Kong and production based in Mainland China, with whole industry chain layout from R&D to production as well as a global leader in the innovation of therapeutics for immunological and other debilitating diseases. About SinoMab BioScience LimitedSinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus, non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Eisai to Present at The Alzheimer’s Association International Conference (AAIC) 2022

TOKYO, Jul 26, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co. Ltd announced today that the company will present research from its Alzheimer's disease (AD) pipeline, including new data for lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, at the Alzheimer's Association International Conference (AAIC) to be held in San Diego, CA and virtually from July 31 to August 4, 2022. Eisai will present data and research in three oral and 18 poster presentations at the meeting.On July 5, 2022 (U.S), Eisai announced that the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for lecanemab under the accelerated approval pathway and was granted priority review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023. The readout of the primary endpoint data of Clarity AD will occur in the Fall of 2022. The FDA has agreed that the results of Clarity AD when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab.Key Eisai AAIC Presentations- Effect of Genotype on ARIA-E Incidence by Lecanemab: Results from a modeling simulation to evaluate the effect of APOE4 genotype on ARIA-E incidence from study 201 Core and comparison to the observed incidence in the open-label extension among those newly treatedwith lecanemab. (Virtual Developing Topics #69402) - Lecanemab Subcutaneous Dosing:Results from a study in healthy subjects to evaluate the absolute bioavailability, pharmacokinetics, safety, and immunogenicity of lecanemab following a single fixed 700 mg subcutaneous dose. (Poster/Abstract #69438)Modeling and simulation analysis aimed at showing the equivalence of fixed weekly subcutaneous dose of lecanemab to body weight-based 10mg/kg biweekly intravenous dose. (Poster/Abstract #69429)- Ethnic and Racial Diversity in Eisai Clinical Trials: An evaluation of US enrollment across lecanemab (Study 201 and Clarity AD) and elenbecestat MissionAD studies in early AD to assess racial and ethnic groups and the impact of eligibility criteria in the United States. (Poster/Abstract # 69198)- Beta-Amyloid Assays Predict Brain beta-Amyloid Pathology: Data from the Eisai and Sysmex collaboration reporting on the fully automated plasma Abeta40 and Abeta42 immunoassays and their performance for predicting brain Aβ pathology defined by amyloid PET. (Poster/Abstract # 68727) - Comprehensive CSF Tau Profiling from Dominantly Inherited Alzheimer Network (DIAN): An oral presentation that shares results from a study in patients enrolled in Washington University School of Medicine's DIAN-observational cohort that used Eisai's anti-microtubule binding region (MTBR) antibody, E2814, to profile MTBR-tau and then assessed timing to MTBR-tau changes in CSF and correlation to clinical, cognitive, and biomarker changes. (Oral Presentation # 65313)"The lecanemab data Eisai will present at AAIC 2022 continues to build the body of knowledge about our investigational anti-amyloid beta protofibril antibody as we work toward the Phase 3 confirmatory Clarity AD readout this fall," said Michael Irizarry, M.D., Senior Vice President, Deputy Chief Clinical Officer, Alzheimer's Disease and Brain Health, Eisai Inc. "Additional research presented will highlight Eisai's efforts to improve ethnic and racial diversity in our early Alzheimer's disease clinical trials in the United States so that study populations mirror the U.S. Medicare population, as well as research from our collaboration with Sysmex on potential biomarkers that may contribute to early diagnosis of Alzheimer's disease."For more information, visit https://www.eisai.com/news/2022/pdf/enews202257pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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TrialWire Technology Platform Rolls Out World First SMS/Text Patient Contact System Across all Studies Globally

ADELAIDE, AUS, Jul 20, 2022 - (ACN Newswire via SEAPRWire.com) - TrialWire(TM) Technology Platform, the most secure and rapid digital patient recruitment Platform for trial rescue, today announced the rollout of the proprietary SMS/Text patient contact system across all studies globally.The SMS/Text patient contact system is a world first in speed, security, and compliance for study coordinators contacting patients to discuss their study application and site bookings.It is primarily designed to speed up the contact process which is typically delayed using phone or email. Up to 50% of patients can be lost due to contact failure because they often don't answer an unknown number call from a site. In addition, study coordinators often can't afford the time to call more than 3-4 times in the hope of connecting with the patient.TrialWire has found from patient responses that 92% want to be contacted by SMS/Text so this was a driving force behind the development and rollout of the service. This includes studies for older people.The SMS/Text system can support all languages and keeps a record in the study coordinator's Dashboard of all conversations.Most study coordinators are using the contact system to arrange then confirm times for screening calls, or site screening visits.TrialWire recruitment can start in under 24-hours because the Platform doesn't require approvals. The TrialWire Technology Platform includes:- Dedicated secure dashboards for each Study Coordinator where they can review patient details and medical information- Multiple dashboards per site so all Study Coordinators can see real-time progress- Dashboards for sponsors and CROs where they can see de-identified referral status information- Secure SMS system inside their dashboards for instant communications with the patient - book calls and screening visits- Automated AI-Match and algorithm-driven "find and screen" patients process- Minute-by-minute metrics for Study Coordinators showing numbers referred, contacted, screened, and enrolled at their site- Minute-by-minute metrics for sponsors and CROs showing numbers referred, contacted, screened, and enrolled - across all sites on a study- HIPAA compliance and all patient privacy security - Built on the Salesforce Health Cloud- Unlimited number of sites globally- Available in all languages With more than 80% of clinical trials failing to recruit patients on time, and 30% of research sites not able to meet enrollment goals - 10% of sites don't enroll any patients - TrialWire offers peace of mind for sponsors and their CROs.TrialWire is ideal for sponsors and CROs wanting to avoid extended recruitment delays.Request more information here - starts in 24 hours https://trial-wire.com/contact/Learn more here https://www.trial-wire.com/About TrialWire www.trial-wire.comTrialWire is a privately held technology company that leverages 25 years of experience in the clinical trial patient recruitment sector. TrialWire, which is solving the most serious problem in the drug development sector, has a recent valuation of USD$27m. Its mission is to end the patient recruitment crisis delaying the development of new therapies which is costing drug companies billions of dollars a day due to problems finding the right people quickly and enrolling them at the site level.The TrialWire Platform is the most secure service (powered by Salesforce Health Cloud) that uses advanced algorithms to find the right people who are online that might be suitable for studies available on the Platform. They are invited into the Platform and taken through the AI-Match screener to determine an exact match to a study - site-based or remote/virtual. No account sign-up is required to find and apply for a study. The Platform ingests study data from approved trial registries like ClinicalTrials.Gov. It uses advanced online algorithms to find patient/trial matches based on detailed demographic and location profiles.Key to the TrialWire success is that it finds motivated people who are actively online trying to find out more about their conditions. They can be connected to a site in under 2 minutes. These people have high retention rates. Unlike all other digital recruitment firms, TrialWire does NOT keep patient details once a study is completed - no databases so no potential privacy breaches. Sponsors are not paying for database building where patients are sent to other studies. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Hua Medicine Published Two Peer-Reviewed Papers in Nature Medicine, an International Top Medical Journal, on the Results of the Phase III Research of Dorzagliatin, a First-In-Class Investigational Diabetes Drug of Hua Medicine

SHANGHAI, CHINA, May 13, 2022 - (ACN Newswire via SEAPRWire.com) - Hua Medicine (the "Company", stock code on the main board of the Hong Kong Stock Exchange: 2552.HK) today announces that, two peer-reviewed papers on the Phase III clinical trial results of dorzagliatin, a glucokinase activator (GKA) and first-in-class investigational drug of the Company for the treatment of diabetes, were published online simultaneously by Nature Medicine, an international top medical journal. These two papers described and analyzed the clinical efficacy and safety characteristics of dorzagliatin monotherapy (SEED) in drug-naive Type 2 diabetes (T2D) patients and the combination therapy of dorzagliatin and metformin (DAWN) in patients who failed in metformin adequacy therapy for the treatment of T2D respectively.It was the first time for Nature Medicine to publish the results of Phase III trials of a GKA, representing the results of large registered clinical studies in China. Dorzagliatin is a new first-in-class GKA antidiabetic drug to successfully complete the Phase III registered clinical study in the world, which was led by Chinese researchers. The two papers are also the first to be published in Nature Medicine with Chinese researchers as the first and corresponding authors of a novel mechanism for treatment of diabetes. Both studies demonstrated that by addressing the defect of the glucose sensor function of glucokinase (GK), dorzagliatin is able to continuously and effectively reduce HbA1c in patients with T2D, and significantly reduce post-meal glucose (2h-PPG) during the treatment period. The percentage of patients admninistered dorzagliatin achieving standard glycemic blood glucose control was demonstrated to be high and with low hypoglycemia incidences. It was also shown that dorzagliatin has good safety and tolerability. In addition, it can continuously improve beta-cell function and reduce insulin resistance.Dorzagliatin is the first-in-class oral drug developed by Hua Medicine for the treatment of T2D after 10 years of independent research and development, which identifies GK as a therapeutic target. GK plays a critical role in maintaining blood glucose homeostasis in human body, serving as a glucose sensor to sense changes of the blood glucose, and timely stimulates glucose control organs to secrete insulin, GLP-1 or glucagon, so as to effectively regulate blood glucose level and maintain blood glucose homeostasis (4-6.5 mmol/L). Impaired sensitivity of glucose, mainly manifested as impaired glucose stimulated insulin secretion (GSIS) function of pancreatic beta-cells and rise of FPG level blood sugar fluctuations, is the root cause of T2D. Dorzagliatin can act on GK in glucose control organs such as pancreas, liver and intestine. By restoring GK activity in T2D patients, it helps restore the sensitivity of the human body to blood glucose changes, and thus improves the early phase insulin secretion and beta-cell function. In this way, blood glucose homeostasis can be rebuilt to control or delay the progression of T2D, and fundamentally treat diabetes and discontinue medication. Hua Medicine has published over 10 papers on the results of basic and clinical studies to continually elaborate its scientific concept of "restoring sensitivity, rebuilding homeostasis, and treating diabetes at its source". The results of the Phase III trial published by Nature Medicine are the clinical validation of this innovative concept. In March 2021, Hua Medicine submitted the new drug application (NDA) of dorzagliatin to the China National Medical Products Administration (NMPA) for T2D treatment, which was accepted in April. Currently, the NDA of dorzagliatin is under active review by the NMPA. Hua Medicine is fully supporting this process to obtain the approval of dorzagliatin as early as possible.Nature Medicine is a top journal, focusing on the field of biomedicine. It mainly publishes original research papers that "demonstrate novel insight into disease processes, with direct evidence of the physiological relevance of the results", and has begun to focus on publishing papers of large clinical research in recent years. The impact factor of Nature Medicine has been on the rise. With a 2-year impact factor of 53.44, it has surpassed Nature to be one of the top five medical journals, also including The New England Journal of Medicine (NEJM), The Lancet, The Journal of the American Medical Association (JAMA) and The British Medical Journal (BMJ), known traditionally as four medical journals. Since 2009, Franz Matschinsky, the father of GK, first reported the research and development of GKA in Nature Reviews Drug Discovery, the theoretical research and drug research and development results related to GKA have drawn worldwide attention, and have been highly valued by the international academic and clinical medical communities. Before, the results of the Phase II clinical trial of dorzagliatin were published in the advanced medical journal The Lancet Diabetes and Endocrinology. Since 2014, Hua Medicine has been presenting the results of basic researches and clinical studies of dorzagliatin at the world's largest and most important diabetes conference - the American Diabetes Association (ADA) Scientific Sessions every year. It was through the ADA Scientific Sessions that the editors of Nature Medicine noticed the innovativeness and breakthrough nature of dorzagliatin, and took the initiative to make an appointment with Hua Medicine for scripts. These two newly published papers present the Phase III results of the SEED study and the DAWN study of dorzagliatin, respectively.The SEED study is a study of dorzagliatin monotherapy. It is a randomized, double-blind and placebo-controlled Phase III registered clinical study in drug naive T2D patients. The study was conducted among 463 T2D patients. The first 24 weeks were randomized, double-blind and placebo-controlled treatment, designed to evaluate the primary efficacy and safety endpoints of dorzagliatin. The subsequent 28 weeks were open-label period for dorzagliatin, designed to continuously observe and evaluate the safety of dorzagliatin. The SEED study was led by Professor Dalong Zhu, the President of the Chinese Diabetes Society, and Director of Medical Center for Endocrine and Metabolic Diseases of Gulou Hospital, affiliated to Medical College of Nanjing University. This study showed that dorzagliatin can effectively reduce the blood glucose of drug naive T2D patients, with good safety and tolerability. The main conclusions of the SEED study include:Significant and long-lasting efficacy:-- There was a 1.07% HbA1c reduction from baseline in 24 weeks, significantly better than that of the placebo treated group (p-- The standard-reaching rate of HbA1c was 42.5% in 24 weeks, significantly higher than that of the placebo treated group (p-- Significantly improved beta cell function, with a 3.28 increase in HOMA2-beta in 24 weeks compared with the placebo treated group-- The 2h-PPG observably decreased by 2.33mmol/L compared with the placebo treated group in 24 weeks-- The FPG observably decreased by 0.33mmol/L compared with the placebo treated group in 24 weeks-- The HbA1c continued to remain steady in 52 weeksGood tolerability and safety:-- The hypoglycemia (-- The hypoglycemia (-- In 52 weeks, there was no drug-related SAEThe DAWN study is a randomized, double-blind, placebo-controlled Phase III study among 767 patients, which uses dorzagliatin combined with metformin to treat T2D patients who failed in metformin adequacy therapy. The first 24 weeks were randomized, double-blind and placebo-controlled treatment, designed to evaluate the primary efficacy and safety endpoints of dorzagliatin. The subsequent 28 weeks were open-label period for dorzagliatin, designed to continuously observe and evaluate the safety of dorzagliatin. The DAWN study was led by Professor Wenying Yang at China-Japan Friendship Hospital, who is the former President of the Chinese Diabetes Society and present Vice President of the Asian Diabetes Association. This study showed that dorzagliatin can effectively reduce the blood glucose of T2D patients who failed in metformin adequacy therapy, with good safety and tolerability. The main conclusions of the DAWN study include:Significant and long-lasting efficacy:-- The HbA1c reduction was 1.02% from baseline, significantly better than that of the placebo treated group in 24 weeks-- The standard-reaching rate of HbA1c was 44.4% in 24 weeks, significantly higher than 10.7%(p-- Significantly improved beta cell function and HOMA2-beta increased by 2.43 compared with the placebo treated group in 24 weeks-- The 2h-PPG observably decreased by 2.48mmol/L compared with the placebo treated group in 24 weeks-- The FPG observably decreased by 0.38mmol/L compared with the placebo treated group in 24 weeks-- The HbA1c continued to remain steady in 52 weeksGood tolerability and safety:-- The hypoglycemia (-- The hypoglycemia (-- In 52 weeks, there was no drug-related SAEProfessor Dalong Zhu, the first author of the paper on SEED, said, "The investigator team of dorzagliatin and the R&D team of Hua Medicine have always focused on the clinical needs of patients and adhered to scientific rigor to successfully develop this first-in-class new drug together. The publication of the results of the two Phase III clinical studies on Nature Medicine is another proof of the international academic community recognizing China's new drug development capabilities. As a clinical investigator, I feel very proud and confident about the future of innovative drug development in China. In clinical trials, dorzagliatin has demonstrated long-lasting and stable efficacy, as well as good safety and tolerability. In the meanwhile, it showed significant potentiation in combination trials with SGLT-2 inhibitors and DPP-4 inhibitors. I am very much looking forward to bringing new treatment options with dorzagliatin to Chinese T2D patients soon."Professor Xiaoying Li, the co-corresponding author of the paper and Director of the Department of Endocrinology at Zhongshan Hospital affiliated to Fudan University, said, "Nature Medicine is a top journal with a high impact factor. The clinical trial of dorzagliatin is designed in line with the standards of international multinational companies. All the investigators and developers followed a high bar of standards and quality, which led to the creation of such a high-value breakthrough drug. I'm very proud and excited about this achievement. Type 2 diabetes is a critical threat to human health. As clinicians, our involvement in the clinical development of dorzagliatin has given us the opportunity to review the regulating mechanisms of glucose homeostasis and to better understand the process and characteristics of the progression of type 2 diabetes. "Professor Wenying Yang, the first author of the DAWN paper, said, "I am very excited and happy! Before, the results of Phase II clinical study of dorzagliatin were published in The Lancet Diabetes and Endocrinology, and now the results of Phase III clinical study were published in Nature Medicine. Such achievements are completely on par with the first-in-class diabetes drugs developed by multinational pharmaceutical companies. This is a great recognition on Chinese innovative drugs, the best return to Hua Medicine and Dr. Chen Li's 10 years of hard work, and the most memorable experience for us as clinical investigators. We are fortunate to meet such a good pioneer. I look forward to the launch of dorzagliatin soon!"Dr. Yi Zhang, Chief Medical Officer, Senior Vice President of Pharma Development of Hua Medicine and the head of clinical development for dorzagliatin, said, "The publication of the results of the two clinical studies, i.e., the SEED study and the DAWN study, on Nature Medicine fully demonstrated the scientific research capabilities of Chinese clinical researchers and Hua Medicine's innovative R&D strengths as a China-based biopharmaceutical company. The Phase III clinical trial of dorzagliatin is the first confirmatory clinical study of GKA drugs completed worldwide. It is also the first clinical trial of a first-in-class investigational diabetes drug led by a Chinese clinical team with Chinese subjects as the research objects. We are very grateful to all clinical researchers for their unremitting efforts and hard work. In the future, Hua Medicine is confident to join hands with partners in various clinical fields to make new breakthroughs in the field of Type 2 diabetes and the whole metabolic diseases."Dr. Li Chen, Founder, CEO, Chief Scientific Officer of Hua Medicine and corresponding author of both papers, said, "We are very pleased to collaborate with Jennifer Sargent, Editor-in-Chief, to publish the clinical research results of dorzagliatin in Nature Medicine. This illustrates the strong interest and attention of the international medical community on the GK mechanism and GKA drugs. In 1968, Professor Franz Matschinsky, the father of glucokinase, discovered the critical role of GK in glucose-stimulated insulin secretion and proposed glucokinase as a diabetes gene and glucose sensor. The drug development of glucokinase activators has, since then, undergone numerous difficulties and failures. More than 50 years later, I am very pleased to see that Hua Medicine R&D team and Chinese clinical experts, after ten years of hard work, have overcome many R&D difficulties and greatly improved the understanding of glucokinase's role in the regulation of blood glucose homeostasis and diabetes treatment, established the world's leading scientific concept of diabetes treatment, and successfully transformed it into the breakthrough new drug dorzagliatin. The recently results of the DREAM study, further elucidates that dorzagliatin can fundamentally treat T2D and achieve diabetes remission without any glucose-lowering medication after the completion of the SEED study. Hua Medicine is proactively supporting the NMPA approval process to bring this innovative drug to the benefit of Chinese type 2 diabetes patients as soon as possible."Design of the SEED studyThe SEED study is a randomized, double-blind and placebo-controlled Phase III study conducted in 463 drug naive T2D patients. The whole study lasted for 53 weeks, including 52 weeks of treatment and 1 week of safety follow-up. The first 24 weeks were randomized, double-blind and placebo-controlled to assess the efficacy and safety of dorzagliatin. Patients were treated with twice-daily doses of dorzagliatin (75mg) or placebo, randomized 2:1. The subsequent 28-week were the open-label treatment period, during which all subjects were treated with twice-daily doses of dorzagliatin (75mg). The study was conducted at 40 clinical sites across China led by Professor Dalong Zhu, the President of the Chinese Diabetes Society, Director of Medical Center for Endocrine and Metabolic Diseases of Gulou Hospital, affiliated to Medical College of Nanjing University. (Clinical study registration number: NCT03173391)Design of the DAWN studyThe DAWN study is a randomized, double-blind, placebo-controlled Phase III study in 767 Type 2 diabetes patients, which uses dorzagliatin combined with metformin to treat patients who failed in metformin adequacy therapy. During the first 24 weeks of double-blinded treatment, subjects were treated with metformin (Glucophage) at 1,500mg/day as the basic therapy, and they were given twice-daily doses of dorzagliatin (75mg) or placebo, randomized on a 1:1 ratio. During the subsequent 28-week open-label treatment period, all subjects received dorzagliatin 75mg twice daily and 1500mg/day of metformin (Glucophage). The trial was conducted in 72 clinical sites across China led by Professor Wenying Yang of China-Japan Friendship Hospital, the former President of the Chinese Diabetes Society and present Vice President of the Asian Diabetes Association. (Clinical study registration number: NCT03141073)About DorzagliatinDorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive and degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By fixing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired insulin and GLP-1 secretion of patients with Type 2 diabetes and serve as a cornerstone therapy targeting the root cause of the disease. Two Phase III registered trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin respectively have been completed in China, as well as the studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). In an investigator-initiated study named as DREAM, a 65.2% diabetes remission rate was observed without any antidiabetes medication during the 52-week study period. The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submitted its NDA to the National Medical Products Administration in order to realize the "First in Global, Start from China" mission for the benefits of diabetic patients worldwide.About Hua MedicineHua Medicine is an innovative drug development company in China focused on developing novel therapies for patients worldwide with unmet medical needs. Hua Medicine teams up with global high caliber people and integrates global resources to explore breakthrough technologies and products and accelerate global innovation in diabetes care. Targeting the glucose sensor glucokinase, dorzagliatin, a novel oral diabetes drug restoring glucose sensitivity in T2D patients, has completed SEED and DAWN registration trials, and filed NDA in China. This global first-in-class glucokinase activator (GKA) has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around the world.For more informationHua MedicineWebsite: www.huamedicine.comInvestorsEmail: ir@huamedicine.comMediaEmail: pr@huamedicine.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway

TOKYO and CAMBRIDGE, Mass., May 10, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401) for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. As part of the completed rolling submission, Eisai has requested Priority Review. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA during fiscal year 2022.The BLA submission for lecanemab is based on clinical, biomarker and safety data from the proof-of-concept Phase 2b (Study 201 Core) in 856 people with early AD with confirmed presence of amyloid pathology, biomarker and safety data from the Study 201 OLE (open-label extension study, 180 subjects), and blinded safety data from the confirmatory Clarity AD Phase 3 study (1,795 subjects). The large number of participants across these studies provides the FDA with extensive safety data. Study 201 explored the impact of treatment with lecanemab on reducing amyloid plaque and clinical decline. At 18 months of treatment, 10 mg/kg biweekly lecanemab reduced brain amyloid by a mean of 0.306 SUVr units (from a baseline mean of 1.37), and over 80% of subjects became amyloid negative by visual read. Furthermore, the extent of reduction in amyloid was correlated with slower clinical decline on ADCOMS (Alzheimer's Disease Composite Score), CDR-SB (Clinical Dementia Rating-Sum-of-Boxes), and ADAS-cog (Alzheimer Disease Assessment Scale-Cognitive Subscale) at the treatment group and patient level. In the Core study, the overall rate of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with anti-amyloid beta antibodies therapies was 9.9% (16/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 0.8% (2/245) of placebo patients. The results from Study 201 were published in a peer-reviewed journal Alzheimer's Research and Therapy in April 2021."We would like to thank the people living with early AD and the healthcare professionals who participated in the lecanemab 201 study for their cooperation allowing completion of this BLA to the U.S. FDA. Alzheimer's disease is a progressive and devastating disease with few treatment options," said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. "Eisai employees have spent time with people living with Alzheimer's disease and their families to truly understand their feelings and challenges and have been working to create new treatments for many years. Our comprehensive medicine creation approach along the Alzheimer's disease continuum reflects Eisai's long-term commitment to providing innovative treatments to the people living with AD, their families and healthcare professionals who urgently need new treatment options.""With Alzheimer's disease, patients and their loved ones don't have the luxury of time. There is an enormous unmet need in this space, and we continue to make progress in advancing additional treatment options for people living with this devastating disease," said Michel Vounatsos, Chief Executive Officer at Biogen. "Anti-amyloid antibodies are a new wave of important medicines, which could provide patients and their physicians more options in addressing this complex disease."Lecanemab was granted Breakthrough Therapy and Fast Track designations by the FDA in June and December 2021, respectively. In March 2022, Eisai initiated submission of application data to the Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system in Japan with the aim of obtaining early approval for lecanemab, and aims to file for the manufacturing and marketing approval based on the results of Clarity AD during Eisai's fiscal year 2022.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.About Lecanemab (BAN2401)Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Abeta) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Currently, lecanemab is being developed as the only anti-Abeta antibody that can be used for the treatment of early AD without the need for titration. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain Abeta accumulation (P Currently, lecanemab is being studied in a confirmatory Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. * Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment.** An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placebo. About the Collaboration between Eisai and Biogen for Alzheimer's DiseaseEisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of lecanemab. About the Collaboration between Eisai and BioArctic for Alzheimer's DiseaseSince 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD. About Eisai Co., Ltd.Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com. About BiogenAs pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need. In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities. The company routinely posts information that may be important to investors on our website at www.biogen.com.MEDIA CONTACT: Eisai Co., Ltd.Public Relations Department+81-(0)3-3817-5120Biogen Inc.Ashleigh Koss+ 1-908-205-2572public.affairs@biogen.com Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Joint Feasibility Study on the Commercialization of Sustainable Aviation Fuel

TOKYO, Apr 19, 2022 - (JCN Newswire via SEAPRWire.com) - ENEOS Corporation and Mitsubishi Corporation have agreed to undertake a joint feasibility study aimed at commercializing Sustainable Aviation Fuel (SAF) and other next-generation fuels in Japan. This study aims to build a supply chain for SAF, which requires cross-industrial collaboration, by leveraging both companies' respective strengths. These include ENEOS' manufacturing technologies and distribution networks, together with MC's global expertise in raw material sourcing and marketing capabilities.After formulating a basic strategy that takes into account the maturity of various SAF manufacturing technologies and the necessary time for commercialization, ENEOS and MC will proceed with the study based on the following three approaches: (1) Developing sustainable feedstock derived from bio-based raw materials(2) Producing SAF with newly emerging techniques(3) Building a supply chain for next generation fuels, with a focus on SAF In the aviation industry, there is growing momentum towards the adoption of SAF in Europe and North America in order to align with CORSIA*, Carbon Offsetting and Reduction Scheme for International Aviation that will commence in 2027. This would drive the growth of the SAF market on a global scale going forward.In addition, the Japanese government has proposed a target to replace 10 percent of the jet fuels consumed by Japanese airlines with SAF by 2030. This makes establishing a SAF supply chain in Japan an urgent issue. ENEOS and MC put a high priority on addressing climate change issues, and both companies are actively promoting initiatives to reduce CO2 emissions with the aim of helping to achieve a decarbonized, circular society.By proceeding with this study as part of the above efforts, ENEOS and MC will be steadily contributing toward the early establishment of a supply chain for next-generation fuels. *An environmental measure in the aviation industry: In 2016, the International Civil Aviation Organization (ICAO) adopted at its annual meeting the Carbon Offsetting and Reduction Scheme for International Aviation (CORSIA) aiming to achieve international aviation growth without increasing CO2 emissions from 2021. Inquiry Recipient:Mitsubishi CorporationTelephone:+81-3-3210-2171Facsimile:+81-3-5252-7705 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Eisai: Latest Findings on Lecanemab Presented at AD/PD 2022 Annual Meeting

CAMBRIDGE, Mass., and TOKYO, Mar 22, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer's disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) March 15-20 in Barcelona, Spain and virtually.Four key symposium presentations explored how lecanemab's clinical efficacy data, overall amyloid-related imaging abnormality (ARIA) rates, biomarker relationships to clinical outcomes, potential dosing regimens, and administration have the potential to benefit people living with early AD.1. Science of the Amyloid Cascade and Distinct Mechanism of Action (MoA) of Lecanemab- BioArctic's Professor Lars Lannfelt presented the science of the amyloid cascade and studies evaluating lecanemab's distinct binding profile to antibodies created from patented sequences of two other clinical antibodies, aducanumab and gantenerumab. The three antibodies have different binding profiles to Abeta species. All three antibodies bind to fibrils, but with different selectivity. Lecanemab was the strongest Abeta binder and prefers protofibrils. Lecanemab's binding profile is critical to enriching our understanding of the features in clinical outcomes and safety. BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD.2. Key Trial Design Aspects and Clinical Outcomes of the Lecanemab Phase 2b (Study 201) Trial and Open-Label Extension (OLE) in Early AD- Innovative Bayesian Adaptive Randomization Design and Dose Regimen-Finding Study with OLE - Study 201 (published by Eisai in Alz Res Therapy 13;21) was prospectively designed as a blinded 18-month study. To accelerate the development program, Eisai used a Bayesian adaptive design with a prespecified 12-month Bayesian primary endpoint in addition to the prespecified traditional analysis at the end of the 18-month treatment period. The OLE evaluated the long-term safety and tolerability of lecanemab and the effect of lecanemab on amyloid PET over 12 months of treatment, which looked at treatment naive patients (those on placebo during the core study) and those patients who had previously been treated with lecanemab, including earlier time points (3 and 6 months) than in the core phase (12 and 18 months). Eisai's study design provided the opportunity to explore the biomarker and clinical effects of stopping and restarting lecanemab across five years of disease trajectory.- Rapid and Thorough Amyloid Clearance Correlates with Clinical Benefit - By using the Bayesian study design across a broad range of doses, researchers were able to efficiently and effectively identify the most effective dose, 10 mg/kg biweekly, to produce rapid and thorough amyloid clearance and potential clinical efficacy. Of the approximately 12 treatment-naive patients in the OLE (those who received placebo in the Core study), more than 40 percent were amyloid negative as early as 3 months and more than 80% were amyloid negative by 12 months as measured by PET image (visual read).(1) The OLE results are consistent with core phase results in which 65% were amyloid negative at 12 months(1) and 81% of participants were amyloid negative at 18 months as measured by PET image (visual read) in 161 subjects treated with 10 mg/kg biweekly dose. Robust amyloid reduction in those receiving lecanemab in the Core study was maintained while off-treatment over the Gap period. Despite the small number of participants in the OLE, findings help confirm the results from the Core study: lecanemab rapidly and thoroughly cleared amyloid plaque from the brain. Study 201 established 10 mg/kg biweekly as the most effective dose of lecanemab based on ADCOMS. Lecanemab could potentially be administered at 10mg/kg on the first day of treatment and continue at biweekly intervals without titration.ARIA Incidence, Frequency, Severity and ModelingARIA-E is an important adverse event of amyloid-lowering therapies that is critical to monitor and manage during treatment.Study 201 Core ARIA-E RatesARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: overall ApoE4 carriers 14.3% (7/49), ApoE4 carriers homozygous 50.0% (5/10), ApoE4 carriers heterozygous 5.1% (2/39) and ApoE4 non-carriers 8.0% (9/112). The overall ARIA-E rate in the Core study was 9.9% (16/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 0.8% (2/245) of placebo patients.Study 201 OLE ARIA-E RatesAlthough ApoE carriers were underrepresented in the 10 mg/kg biweekly group in Study 201 Core, all participants entering Study 201 OLE (69.4% of whom were ApoE4 carriers) were treated with 10 mg/kg biweekly, and ARIA rates were consistent with those in the Core study. Forty-five participants who received placebo in the Core study joined the OLE. ARIA-E was observed in allele groups newly treated with 10 mg/kg biweekly in the OLE at the following rates: overall ApoE4 carriers 12.9% (4/31), ApE4 carriers homozygous 25.0% (1/4), ApoE4 carriers heterozygous 11.1% (3/27) and ApoE4 negative 0.0% (0/14). In the OLE study, overall ARIA-E rates were as follows: ApoE4 carriers 10.4% (13/125), ApoE4 carriers homozygous 14.3% (4/28), ApoE4 carriers heterozygous 9.3% (9/97) and ApoE4 non-carriers 1.8% (1/55).Study 201 Core and OLE Pooled ARIA-E RatesIn the Core and the OLE, ARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: ApoE4 carriers 13.8% (11/80), ApoE4 carriers homozygous 42.9% (6/14), ApoE4 carriers heterozygous 7.6% (5/66) and ApoE non-carriers 7.1% (9/126). The overall ARIA- E rate was 9.7% (20/206) of patients treated with lecanemab 10 mg/kg biweekly.ARIA-E Rates Frequency and SeverityIn the Core study and OLE, the majority of ARIA-E events occurred within the first 3 months of treatment (75% [12/16]) and resolved within 4 months of onset. For the majority of patients, the radiographic severity was mild or moderate; severe radiographic severity was reported in 1.2% (2/161) of patients. The majority of ARIA-E was asymptomatic; with symptomatic ARIA-E reported in 1.9% (3/161) of patients. Symptoms reported in association with ARIA-E included headache, visual disturbance, confusion, aphasia. There has been a single case of ARIA-E associated with seizure in the Core study and OLE to date. Exposure-Response Model Predicted and Observed ARIA-E vs. Cmax for APOE 4The PK/PD exposure-ARIA-E model was developed from the Core study utilizing data from all doses and demonstrated that ARIA-E is driven primarily by Cmax. The ApoE4 genotype is a significant covariate in the model. The PK/PD model predicted ARIA-E by Cmax at the 10 mg/kg biweekly dose in the Core study by allele group as follows: ApoE4 carriers homozygous 22.5%, ApoE4 carriers heterozygous 6.8% and ApoE4 non-carriers 5.4%. In addition to the modeling predicting ARIA-E by Cmax in the Core study, it confirmed the observed ARIA-E in the OLE. Given the small data set for ApoE4 homozygous patients, this will be evaluated in Eisai's Phase 3 Clarity AD clinical trial.ARIA-H RatesIn the Core study, the incidence was higher in ApoE4 homozygous carriers than in ApoE4 heterozygous carriers and non-carriers. ARIA-H was observed in 6.2% (10/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 4.9% (12/245) of placebo patients. The rate of ARIA-H was higher in ApoE4 carriers (12.2% [6/49] vs placebo 5.2% [9/174]), than in ApoE 4 non- carriers (3.6% [4/112] vs placebo 4.2% [3/71]). All patients with microhemorrhage or superficial siderosis were asymptomatic. There has been one report of symptomatic cerebral macrohemorrhage. These data are hypothesis-generating and will be further evaluated in Clarity AD.3. Phase 2b (Study 201) Lecanemab Early AD Study Biomarker Results, Correlations with Clinical Outcomes and Potential Less-Frequent Maintenance Dosing- Abeta42/40 and P-Tau181 are plasma biomarkers that signal sequential changes in AD progression. Lecanemab has an effect on these plasma biomarkers as amyloid plaque reduction is related to soluble amyloid and P-Tau. Lecanemab has a dose- and time-dependent reduction of amyloid plaques with a correlated increase in plasma Abeta42/40 and a decrease in plasma P-Tau181. Changes in plasma Abeta42/40 and P-Tau18 also correlate with change from baseline Clinical Dementia Rating scale Sum of Boxes (CDR-SB). In the Core study, a correlation in change from baseline in amyloid PET SUVR and plasma Abeta42/40 ratio and plasma P-tau181 was observed at 18 months, indicating that plasma biomarkers could potentially help with measuring clinical changes.- When lecanemab treatment was discontinued at the end of the Core study, changes in the plasma Abeta42/40 (47%), P-Tau18 (24%), and amyloid PET SUVR (21%), gradually began to reverse, suggesting stopping therapy prematurely may potentially allow re-accumulation of pathology. Less frequent maintenance treatment to prevent re-accumulation may be possible based on data and modeling. Eisai will further explore maintenance dosing in the subcutaneous substudy of the Study 201 OLE, which will evaluate alternative dosing every 4 weeks or every 12 weeks.- Increasing strong evidence highlights the role of amyloid plaques in triggering tau dysregulation and researchers optimize tau therapeutics by removing a key driver of tau dyshomeostasis (amyloid). For this reason, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, selected lecanemab as the backbone anti-amyloid therapy for anti-tau combination for the ongoing component of the Tau NexGen clinical study, which continues enrollment efforts. 4. Update on Lecanemab Clinical Development, Including New Subcutaneous FormulationEisai's Dr. Michael Irizarry Senior VP of Clinical Research and Deputy Chief Clinical Officer presented updates on key lecanemab clinical trials.- Clarity AD Phase 3: The innovative Bayesian design of lecanemab's robust dose-ranging Phase 2b study allowed Eisai to design the Phase 3 confirmatory Clarity AD clinical trial to verify lecanemab's clinical efficacy and safety in early AD. Enrollment is complete with 1,795 participants globally. Additionally, Eisai's recruitment strategy for the Clarity AD clinical trial ensured greater inclusion of ethnic and racial populations in the U.S., resulting in approximately 25% of the total U.S. enrollment including Hispanic (22.5%) and African American (4.5%) persons living with early AD, which mirrors the U.S. Medicare population. The readout will occur in Fall 2022.- AHEAD3-45 Phase 3 Study in Preclinical AD: As of March 2022, there were over 2,900 people screened, resulting in 287 participants enrolled.- Clarity AD Subcutaneous Substudy: Eisai is developing a subcutaneous formulation of lecanemab with the potential to be administered at home by the patient or caregiver via an auto-injector with a more rapid administration than the IV formulation ("The invited lecanemab presentations at AD/PD provide new and exciting insights into how the mechanism of action of late-stage anti-amyloid antibodies differ and how that may help simplify the patient journey by offering a less frequent dosing regimen while providing long-term benefit," said Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business Group, Eisai. "Eisai aims to bring these potential innovations to people living with early AD and healthcare providers as quickly as possible as we work to fulfill our human health care mission."Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway. Eisai expects to complete this rolling submission in the first quarter of our fiscal year 2022, which begins April 1, 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.(1) Swanson C.et all, November, 9-12, 2021, Clinical Trials On Alzheimer's Disease Annual Meeting, Lecanemab: An Assessment of the Clinical Effects, the Correlation of Plasma Abeta 42/40 Ratio With Changes in Brain Amyloid PET SUVr, and Safety from the Core and Open Label Extension of the Phase 2 Proof-of- Concept Study, BAN2401-G000-201, in Subjects With Early Alzheimer's Disease. Contacts:MEDIA CONTACT:Eisai Co., Ltd.Public Relations Department+81-(0)3-3817-5120Eisai Inc. (U.S.) Libby Holman+ 1-201-753-1945Libby_Holman@eisai.comINVESTOR CONTACT:Eisai Co., Ltd.Investor Relations Department+81-(0)70-8688-9685MEDIA CONTACT:Biogen Inc. Ashleigh Koss+ 1-908-205-2572public.affairs@biogen.comINVESTOR CONTACT:Biogen Inc. Mike Hencke+ 1-781-464-2442IR@biogen.comFor more information, visit https://www.eisai.com/news/2022/pdf/enews202221pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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