Date: 2016-10-31
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Eisai (Japan)
Product: E2609
Action
mechanism: BACE (beta-site APP-cleaving enzyme-1) inhibitor. E2609, discovered in-house by Eisai, is an investigational next-generation oral candidate for the treatment of Alzheimer's disease (AD) that is believed to inhibit BACE, a key enzyme in the production of ABeta. By inhibiting BACE, E2609 decreases ABeta proteins in the brain, potentially improving symptoms and slowing disease progression. Eisai and Biogen are jointly developing E2609 and BAN2401 under a 2014 agreement. This agreement also provides Eisai with an option to jointly develop and commercialize two of Biogen Idec’s candidates for AD, the anti-amyloid beta (A?) antibody BIIB037 (aducanumab) and an anti-tau monoclonal antibody.
Disease: Alzheimer's disease
Therapeutic area: Neurodegenerative diseases
Country:
Trial
details: The first study of the MISSION AD program entitled MISSION AD1 (Study 301) is a global, multicenter, placebo-controlled, double-blind, parallel-group Phase III clinical study aiming to assess the efficacy and safety of E2609 in 1,330 patients with biomarker confirmed early Alzheimer's disease. The treatment group will be administered a dosage of 50 mg of E2609 daily during the treatment period of 24 months, and the primary endpoint will utilize the Clinical Dementia Rating Sum of Boxes (CDR-SB).
Latest
news: * On October 31, 2016, Eisai announced that enrollment has commenced in MISSION AD, a Phase III clinical program of the beta secretase cleaving enzyme (BACE) inhibitor E2609 in patients with early Alzheimer's disease in the United States. E2609 is being jointly developed by Eisai and Biogen Regarding the global conduct of the studies, Eisai and Biogen are currently in consultation with the regulatory authorities in the EU and Japan. The first study of the MISSION AD program entitled MISSION AD1 (Study 301) is a global, multicenter, placebo-controlled, double-blind, parallel-group Phase III clinical study aiming to assess the efficacy and safety of E2609 in 1,330 patients with biomarker confirmed early Alzheimer's disease. The treatment group will be administered a dosage of 50 mg of E2609 daily during the treatment period of 24 months, and the primary endpoint will utilize the Clinical Dementia Rating Sum of Boxes (CDR-SB).
