HighTide Therapeutics Announces First Patient Dosed in Phase 2b Clinical Study Evaluating HTD1801 in NASH (the CENTRICITY study) ACN Newswire

HighTide Therapeutics Announces First Patient Dosed in Phase 2b Clinical Study Evaluating HTD1801 in NASH (the CENTRICITY study)

January 11, 2023
ROCKVILLE, MD and SHENZHEN, CHINA, Jan 11, 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 dosing of the first patient in a Phase 2b clinical study evaluating HTD1801 for the treatment of nonalcoholic steatohepatitis ("NASH").This double-blind, randomized, placebo-controlled, multicentre Phase 2b study will evaluate the effect of HTD1801, 1250 mg twice daily (BID), compared to placebo BID on histologic improvement in adult subjects with NASH and liver fibrosis who also have type 2 diabetes mellitus ("T2DM") or pre-diabetes. The study will enroll approximately 210 subjects with biopsy-confirmed NASH and evidence of stage 2 or stage 3 liver fibrosis. Subjects will receive HTD1801 for up to 60 weeks."Nonalcoholic fatty liver disease ("NAFLD") is the most prevalent chronic liver disease worldwide with a global prevalence of 25.2% to 29.8%. Of those with NAFLD, about 20% have NASH. Patients with NASH and T2DM or prediabetes are at increased risk of progressive liver disease and cardiometabolic complications," said Dr. Liping Liu, founder and Chief Executive Officer of HighTide. "This first patient dosing marks a key milestone for the development of HTD1801 for the treatment of patients with NASH, building on data from our Phase 2a study which showed HTD1801 was associated with meaningful improvements in liver fat, markers of liver Injury and fibrosis as well as cardiometabolic factors (HbA1c, lipids, and weight) after 18 weeks." About NASHNASH, a severe form of nonalcoholic fatty liver disease (NAFLD), is a chronic, complex liver disease characterized by hepatitis - inflammation of the liver - and liver cell damage, which can lead to fibrosis of the liver. NASH can also lead to cirrhosis and liver cancer. NASH patients with T2DM or impaired glucose tolerance are more likely to progress to more severe disease and to develop complications that lead to increased mortality. Prevalence of NASH is on the rise and may soon surpass hepatitis C as a cause for liver transplant in the U.S. and Europe. Currently, there are no approved therapies for NASH.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.ContactsNadia Gaoir@hightidetx.com Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)
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Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer’s Disease JCN Newswire

Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

January 10, 2023
TOKYO, Jan 9, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced Eisai has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) supporting the conversion of the Accelerated Approval of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use to a traditional approval. This sBLA is subject to validation of whether the FDA accepts the application for review. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ("protofibrils")* and insoluble forms of amyloid beta (Abeta), approved under Accelerated Approval Pathway by the FDA on January 6, 2023, for the treatment of Alzheimer's Disease (AD). Treatment with LEQEMBI should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology.Accelerated Approval of LEQEMBI was based on Phase 2 data that demonstrated LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD. Continued approval for this indication is contingent upon verification of LEQEMBI's clinical benefit in a confirmatory trial. The sBLA for LEQEMBI is based on the data from the Phase 3 confirmatory Clarity AD clinical trial. In Clarity AD, LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results, and the profile of Amyloid-Related Imaging Abnormalities (ARIA) incidence was within expectations. 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."We deeply appreciate the cooperation of people living with Alzheimer's disease and healthcare professionals who participated in LEQEMBI's Phase 3 Clarity AD clinical study, which enabled us to submit this sBLA. Alzheimer's disease causes significant impairment and burden to both the people living with this disease and their families, as well as having a profound impact on society," said Haruo Naito, Chief Executive Officer at Eisai. "The fact that Eisai was able to file LEQEMBI's supplemental Biologics License Application for traditional FDA approval on the same day we received accelerated approval demonstrates our commitment to the Alzheimer's disease community and is a major step forward in ensuring access for all those in the U.S living with this disease in need of this medicine. We will continue to actively cooperate with the FDA's review."Eisai has initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022. Eisai plans to file for marketing authorization applications of lecanemab in Japan and EU by the end of Eisai's FY2022, which ends March 31, 2023."Today's filing is an important milestone for people living with Alzheimer's disease, demonstrating the resilience of the scientific and medical communities in their fight against this terrible disease despite the many setbacks and the challenges they've faced," said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen. "We commend Eisai for their leadership on the development of lecanemab and for the speed in which they were able to complete this filing, which is based on important new data from the pivotal late-stage Clarity AD study."Eisai serves as the lead of LEQEMBI 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, 2To learn more, visit www.LEQEMBI.com.For more information, visit www.eisai.com/news/2023/pdf/enews202304pdf.pdf. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)
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Eisai’s Sales Subsidiary Collaborates with Thai Life Insurance to Support Access to Treatments for Dementia, Including Alzheimer’s Disease, in Thailand JCN Newswire

Eisai’s Sales Subsidiary Collaborates with Thai Life Insurance to Support Access to Treatments for Dementia, Including Alzheimer’s Disease, in Thailand

November 4, 2022
TOKYO, Nov 4, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that its Thai sales subsidiary Eisai (Thailand) Marketing Co. Ltd. ("Eisai Thailand") made an agreement to collaborate in supporting access to treatments for dementia, including Alzheimer's disease, in Thailand with Thai Life Insurance Public Company Limited, a leading life insurance company in Thailand.In Thailand, the number of people suffering from dementia is expected to increase significantly from the current 600 thousand to 1.1 million by 2030 due to the rapid aging of the population(1), and the financial burden of the people suffering from dementia, including Alzheimer's disease, and their families due to care is also expected to increase.With this agreement, Eisai Thailand, together with Thai Life Insurance, which has expertise in the design and development of life and medical insurance products, will work together to design insurance products to cover dementia, including Alzheimer's disease raise awareness of the disease, and build a dementia ecosystem to secure access to next-generation Alzheimer's disease treatments in Thailand.Eisai believes that it is Eisai's mission to ensure that patients in need have access to its innovative medicines, and will continue to focus on activities for early consultation and diagnosis, as well as development of patient support programs that take into account the healthcare system and income level of each country.(1) Dementia in the Asia Pacific Region (Alzheimer's Disease International), www.alzint.org/u/Dementia-Asia-Pacific-2014.pdfMedia Inquiries:Public Relations DepartmentEisai Co., Ltd. +81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)
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U.S. FDA Accepts and Grants Priority Review for Eisai’s Biologics License Application of Lecanemab JCN Newswire

U.S. FDA Accepts and Grants Priority Review for Eisai’s Biologics License Application of Lecanemab

July 6, 2022
TOKYO, Jul 6, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for 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. Eisai's application, which was completed in early May 2022, has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023."Alzheimer's disease is a serious disease that causes significant disability and burden to the people living with Alzheimer's disease and their families. Treatment options for Alzheimer's disease are limited and creation of new treatment options is strongly encouraged. Eisai employees have spent time with people living with Alzheimer's disease to truly understand their feelings and challenges and have been working to create new treatments for many years," said Haruo Naito, Chief Executive Officer at Eisai. "The acceptance of lecanemab's BLA with priority review is an important milestone in serving people living with Alzheimer's disease who have been waiting for new treatment options to address an underlying pathology of Alzheimer's disease. We will continue to actively cooperate with the FDA's review in an effort to bring this new treatment option to people living with Alzheimer's disease and their families as soon as possible.""We believe in a future where people living with Alzheimer's disease will have different treatment options to address this complex disease, and today's BLA acceptance with priority review by FDA is an important step towards this vision," said Michel Vounatsos, Chief Executive Officer at Biogen. "Together with Eisai, we are committed to continuing our work to address the tremendous unmet need for these patients and their families."The Clarity AD Phase 3 clinical study for lecanemab in early AD is ongoing and Eisai completed enrollment in March 2021 with 1,795 patients. 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. Eisai utilized the FDA's Accelerated Approval Pathway in an effort to streamline the submission process for the potential traditional approval of lecanemab in order to expedite patients' access to lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai will submit for traditional approval of lecanemab to the FDA during Eisai's fiscal year 2022, which ends on March 31, 2023.In Japan, in March 2022, Eisai initiated the submission of application data to the Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system with the aim of obtaining early approval for lecanemab. Eisai aims to file for the manufacturing and marketing approval based on the results of Clarity AD during Eisai's fiscal year 2022. Also, in Europe, based on the results of the Clarity AD study, Eisai plans to submit a new drug application in 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.For more information, visit www.eisai.com/news/2022/pdf/enews202254pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)
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