Eisai: Data Safety Monitoring Board Recommends Continuation of Phase III Clinical Studies of Bace Inhibitor Elenbecestat in Early Alzheimer’s Disease

Tokyo June 05, 2019 – (JCN Newswire) – Eisai Co., Ltd. announced today that in the 8th meeting of the Data Safety Monitoring Board (DSMB) for the global Phase III clinical studies (MISSION AD) on the investigational oral BACE (beta amyloid cleaving enzyme) inhibitor elenbecestat (development code: E2609) in early Alzheimer’s disease (AD), the DSMB reviewed safety data including the potential for decline in cognition, and recommended the continuation of the studies. Elenbecestat is being jointly developed by Eisai and Biogen Inc.

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

Enrollment in MISSION AD is scheduled to be completed in March 2019.

Eisai aims to create innovative medicines for Alzheimer’s disease as soon as possible in order to further contribute to addressing the unmet medical needs of, as well as potentially increasing the benefits provided to, patients and their families.

Corporate Comm India(CCI Newswire)