American heavyweight Biogen Inc. and Japan's Eisai Co. Ltd. are discontinuing two late-stage trials of its Alzheimer's disease drug aducanumab.
The phase 3 trials, called Engage and Emerge, were stopped after a futility analysis conducted by an independent data monitoring committee showed that the studies were unlikely to meet their main goals. The companies added that the discontinuation of the trials was not due to safety concerns.
The Engage and Emerge trials were evaluating the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia. It was thought that aducanumab could help correct the beta amyloid plaque buildup that is characteristic of the disease.
Biogen's shares slumped 27.32% to $233.00 as of 8:03 a.m. ET in premarket trading. The Tokyo Stock Exchange is closed today.
As a result of the halted trials, Cambridge, Mass.-based Biogen and Tokyo's Eisai are also stopping a phase 2 safety study of the therapy, called Evolve, and a phase 1b long-term extension study, called Prime. The drugmakers plan to start a phase 3 secondary prevention trial of aducanumab once data from Engage and Emerge are further evaluated.
Biogen and Eisai agreed to develop aducanumab and BAN2401 — another Alzheimer's drug — in a collaboration the companies entered in 2014. BAN2401 failed to meet the main goals of a mid-stage study in December 2017.
Alzheimer's disease is the most common cause of dementia. The disorder is characterized by the progressive loss of memory and other mental functions.
The Engage and Emerge trial cancellations are the latest in a long line of failed studies for Alzheimer's therapies as drugmakers continue to face mounting failures and scant successes in search of a cure.
In January, Roche Holding AG decided to discontinue two late-stage trials evaluating its drug crenezumab in patients with Alzheimer's disease for the same reason. In June 2018, Eli Lilly and Co. and AstraZeneca PLC similarly stopped two late-stage trials of Alzheimer's drug lanabecestat following recommendations from an independent data-monitoring committee.
Pfizer Inc. also announced in January 2018 that it will stop trying to discover new drugs for Alzheimer's disease and Parkinson's disease, while in the same month Axovant Sciences Ltd. scrapped development of its experimental Alzheimer's disease treatment intepirdine after the drug failed to meet its main goals in multiple trials.