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Eisai and Biogen stop two Phase III clinical studies of elenbecestat in early Alzheimer’s disease

Friday 13 September 2019

On 13 September, Eisai and Biogen announced the decision to discontinue two Phase III clinical studies based on data safety monitoring board recommendation. The MISSION AD1 and MISSION AD2 Phase III studies were multicentre, placebo-controlled, double-blind and parallel-group trials designed to assess the efficacy and safety of elenbecestat, a BACE inhibitor, in a total of 2.100 people with mild cognitive impairment or mild Alzheimer’s disease (AD). Participants were assigned to receive either placebo or 50mg of elenbecestat daily for two years.

Elenbecestat was the last active BACE inhibitor tested for AD in clinical trials. The decision to discontinue the Phase III studies is based on the results of a safety review, which suggested an unfavourable risk-benefit ratio. Data is expected to be presented at upcoming conferences.

The long-term extension of the Phase II trial of elenbecestat, will also be discontinued. The companies reported that the discontinuation of the MISSION AD program will not affect the ongoing Phase III Clarity AD trial of BAN2401, an anti-amyloid-beta monoclonal antibody, in participants with early AD.

https://www.eisai.com/news/2019/pdf/enews201965pdf.pdf

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