Phase III MISSION programme of two trials of elenbecestat are initiated by Eisai and Biogen for treatment of Alzheimers disease

Eisai Co., Ltd. announced that enrollment has commenced in Japan for MISSION AD1, a global Phase III clinical study of the in-house developed oral beta secretase cleaving enzyme (BACE) inhibitor elenbecestat (development code: E2609) in patients with early Alzheimer's disease (AD).

The Phase III clinical trial program for elenbecestat (MISSION AD) consists of two global Phase III clinical studies with the same 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 of early AD, including mild cognitive impairment due to AD and a subset of very mild AD, in 1,330 patients with positive biomarkers for brain amyloid pathology. Patients are administered a dosage of 50 mg of elenbecestat daily during the treatment period of 24 months, and the primary endpoint will utilize the Clinical Dementia Rating Sum of Boxes (CDR-SB).

MISSION AD1 commenced first in the U.S. in October 2016 and the enrollment has been progressing steadily. MISSION AD2 commenced in the U.S in December 2016, and will commence in Japan shortly. Additionally, in Europe, applications for both clinical studies have been submitted, and preparations to begin are underway.

Elenbecestat is being jointly developed by Eisai and Biogen Inc.