Biogen Halts Alzheimer’s Drug Trials

Biogen and partner Eisai have announced the decision to discontinue the global Phase 3 trials 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.

“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience….” said Michel Vounatsos, CEO at Biogen. “Biogen’s history has been based on pioneering innovation, learning from successes and setbacks.  Driven by our steadfast commitment to patients and our strong business foundation, we will continue advancing our pipeline of potential therapies in Alzheimer’s disease and innovative medicines for patients suffering from diseases of high unmet need.”

Aducanumab (BIIB037) is an investigational compound being studied for the treatment of early Alzheimer’s disease. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Aducanumab is a human monoclonal antibody (mAb) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune’s technology platform called Reverse Translational Medicine (RTM).

Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. In addition, the FDA has granted Fast Track designation for the development of aducanumab, a process allowing priority reviews by the FDA for drugs deemed as having potential to treat serious conditions and tackle key unmet medical needs. (Source: Biogen Website, 21 March, 2019)