Biogen Spooks With Phase III Aducanumab Changes

Recruiting more patients into a trial to retain statistical power is standard practice, but with other companies discontinuing late-stage investigational Alzheimer's therapies, the difficulty in maintaining confidence in the development of new therapies for the condition has been underlined by investor responses to Biogen's alterations.

Brain
Loss of cognition is often seen in Alzheimer's disease patients • Source: Shutterstock

Biogen Inc.'s decision to increase the patient size of its two ongoing Phase III studies of the potential Alzheimer's therapy, aducanumab, as specified in study protocol and without unblinding the studies, has worried investors, with the concerns coinciding with a sharp 6.6% drop in the company's share price on Nasdaq to $296.08 on Feb. 14, the day the changes were revealed.

There have been numerous failures of potential Alzheimer's disease therapies in development, but sensitivities may have been heightened by the announcement just a day earlier that Merck & Co....

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