Biogen Stock Crashes on Termination of Alzheimer's Studies

A sign marks a Biogen facility in Cambridge

But it was said that this has issues too as it does not have any safety concerns. This study used Bayesian Adaptive Randomization Design to automatically allocate newly enrolled patients into the study to treatment arms showing higher probability of efficacy based on the results of interim analyses. Despite that dominance, drug development in Alzheimer's has yielded a long string of failures.

But in addition to dealing a significant blow to Biogen - aducanumab was its lead product candidate - the news did the same to the amyloid beta hypothesis, which for decades has been the dominant hypothesis of what causes the disease and how to treat it.

"It has to be early detection and early treatment, years before symptoms begin, for it to work", Tanzi said. It is still assessing whether to conduct a separate aducanumab late-stage prevention trial.

Alzheimer's treatments are known as being particularly hard to develop, as both diagnosis and the recruitment of appropriate trial participants are challenging.

Drug giant Merck used a different approach to fight beta-amyloid in people with late-stage Alzheimer's with its BACE inhibitor verubecestat but admitted defeat in early 2017 after an independent study found that it had "virtually no chance" of working. That's despite analysts' expectations that the second drug would also likely be discontinued. Although aducanumab is only the latest of those failures, Cowen analyst Phil Nadeau wrote in a note to clients Thursday that aducanumab's clear ability to remove amyloid beta from the brain makes it hard to see how other amyloid beta-targeting antibodies could succeed. The analysis showed that the studies are unlikely to meet their primary endpoints.

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"This disappointing news confirms the complexity of treating Alzheimer's disease and the need to further advance knowledge in neuroscience", Biogen Chief Executive Officer Michel Vounatsos said.

He added, "We are incredibly grateful to all the Alzheimer's disease patients, their families and the investigators who participated in the trials and contributed greatly to this research".

Those finer details may uncover ways in which amyloid-attacking drugs might be helpful to those diagnosed with Alzheimer's, Isaacson said. Last year, Pfizer stopped trying entirely to find Alzheimer's therapies, shutting down its research on both it and Parkinson's disease and cutting about 300 jobs.

The treatment group will be administered a dosage of 10 mg/kg bi-weekly of BAN2401, with patients allocated in a 1:1 ratio to receive either placebo or the treatment group.

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