Biogen (NASDAQ:BIIB) and partner Eisai are discontinuing two global Phase 3 trials to evaluate the efficacy and safety of aducanumab in Alzheimer’s disease (AD).
Aducanumab is a monoclonal antibody designed to slow AD progression by targeting amyloid plaques. The objectives of the two trials, called ENGAGE and EMERGE, were to evaluate aducanumab’s ability to slow cognitive and functional impairment, compared with placebo.
The studies were discontinued based on a futility analysis by an independent data monitoring committee, which indicated that aducanumab is unlikely to meet its primary endpoint upon trial completion.
Biogen will also discontinue a Phase 2 safety study and a Phase 1b long-term extension study of aducanumab. The company will decide whether to initiate a Phase 3 secondary prevention trial based on further evaluation of the ENGAGE and EMERGE data.
