Eisai and Biogen discontinue phase III trials, ENGAGE and EMERGE

Biogen and Eisai, Co., Ltd. announced the decision to discontinue the global Phase III trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. The decision to stop the trials is based on results of a futility analysis conducted by an independent data monitoring committee, which indicated the trials were unlikely to meet their primary endpoint upon completion.

The recommendation to stop the studies was not based on safety concerns. Detailed data from the ENGAGE and EMERGE studies will be presented at future medical meetings to inform ongoing research.

As part of this decision, the EVOLVE Phase II safety study and the long-term extension of the PRIME Phase 1b study of aducanumab will also be discontinued. Initiation of the aducanumab Phase III secondary prevention trial will be assessed while the data from ENGAGE and EMERGE are further evaluated.