Sep 13, 2019 18:43 JST

Source: Eisai

Eisai and Biogen to Discontinue Phase III Clinical Studies of Bace Inhibitor Elenbecestat in Early Alzheimer's Disease

Discontinuation of studies based on Data Safety Monitoring Board recommendation

TOKYO, Sep 13, 2019 - (JCN Newswire) - Eisai Co., Ltd and Biogen Inc. today announced the decision to discontinue the Phase III clinical studies (MISSION AD1, AD2) on the investigational oral BACE (beta amyloid cleaving enzyme) inhibitor elenbecestat (development code: E2609) in patients with early Alzheimer's disease (AD). The decision is based on the results of a safety review conducted by the Data Safety Monitoring Board (DSMB), which recommended to discontinue these trials due to an unfavorable risk-benefit ratio. Detailed data of these studies will be presented at future medical meetings.

Investigators are being informed of the decision and they will be contacting their study participants to discontinue the investigational treatment.

Dr. Lynn Kramer, Chief Clinical Officer, Neurology Business Group, Eisai Co., Ltd., said: "We would like to thank the patients and the families, as well as medical professionals, that participated in the MISSION AD studies. Without their contributions we would not be able to advance Alzheimer's disease research. We are very disappointed with the news, and intend to learn from these data and continue engaging with patients and investigators, to pursue the discovery of new medicines for Alzheimer's disease."

The Phase III clinical trial program for elenbecestat (MISSION AD) consisted of two global Phase III clinical studies with identical protocols, MISSION AD1 (Study 301) and MISSION AD2 (Study 302). Both studies were multicenter, placebo-controlled, double-blind, parallel-group Phase III clinical studies designed to assess the efficacy and safety of elenbecestat for treatment in a total of about 2,100 patients with mild cognitive impairment (MCI) or mild AD (collectively known as early AD) with confirmed amyloid pathology in the brain. Patients were randomized to receive either 50 mg of elenbecestat or placebo daily during the treatment period of 24 months, and the primary endpoint was the Clinical Dementia Rating Sum of Boxes (CDR-SB).

As part of this decision, the long-term extension of the Phase II clinical trial of elenbecestat (Study 202) will also be discontinued. This determination does not impact the program of the anti-amyloid beta (Abeta) protofibril monoclonal antibody BAN2401, and the Phase III Clarity AD trial of BAN2401 will continue.


About Eisai
Eisai Co., Ltd. defines our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through working with key stakeholders to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit https://www.eisai.com


Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120
Source: Eisai
Sectors: BioTech

Copyright ©2020 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Eisai to Launch New Selbelle Premium Tablets and New Selbelle Premium Fine Granules
May 18 2020 12:33 JST
 
Eisai to Present Data on Oncology Pipeline and Products at ASCO20 Annual Meeting
May 14 2020 08:22 JST
 
Eisai Selected as Most Honored Company and the First Place of the Sector in "The All-Japan Executive Team (Best IR Company Ranking)" by Institutional Investor Magazine
April 27 2020 16:26 JST
 
Eisai and Seikagaku Enter into Agreement for the Co-development and Marketing Alliance of SI-613, a Treatment of Osteoarthritis, in China
April 01 2020 15:23 JST
 
Eisai Submits Marketing Authorization Application in Japan for Anticancer Agent Denileukin Diftitox (Genetic Recombinant)
March 26 2020 16:01 JST
 
Eisai's Discovery Research on Multikinase Inhibitor Lenvatinib Honored with PSJ Award for Drug Research and Development '20
March 25 2020 08:38 JST
 
Eisai to Launch Digital Tool "NouknowTM" in Japan for Regular Self-Assessment of Brain Performance (Brain Health)
March 23 2020 10:53 JST
 
Eisai: All-case Surveillance Condition for Approval of "Actonel 17.5 mg tablets" for Treatment of Paget's Disease of Bone Cleared in Japan
March 19 2020 14:15 JST
 
Eisai and FUJI YAKUHIN Conclude License Agreement Concerning the Development and Distribution of Dotinurad, a Treatment for Hyperuricemia and Gout, in China
February 25 2020 08:10 JST
 
Eisai Receives the President's Award of the Japan Techno-Economics Society at the 8th Technology Management and Innovation Awards
February 21 2020 16:55 JST
 
More Press release >>

Latest Press Release


More Latest Release >>