Potential Alzheimer’s Treatment, Now in Phase 3 Testing, Gets Boost from FDA

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Aducanumab, an amyloid-fighting medication being developed by Biogen for Alzheimer’s disease (AD), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The treatment is currently being evaluated in two large-scale Phase 3 trials, both of which are recruiting Alzheimer’s patients.

The FDA’s fast track program allows for faster approval of medications for serious conditions that are not adequately treated, such as AD.

“By collaborating with regulators through programs like Fast Track, we hope to bring effective treatments to patients and families affected by Alzheimer’s disease as quickly as possible,” Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, said in a press release.

Aducanumab is thought to block beta-amyloid from sticking together in what are known as plaques, stopping the toxic protein from forming cell-killing deposits in the brains of people with AD. Based on animal studies and initial brain imaging data in humans, aducanumab seems to reduce amyloid plaques.

Two global studies, ENGAGE (NCT02477800) and EMERGE (NCT02484547), are now in progress. The trials are evaluating the safety and effectiveness of aducanumab  in delaying cognitive impairment and disability in people with early AD. Anyone interested in learning more about these Phase 3 trials — taking place across the U.S., Canada, Europe and elsewhere — can do so through this website provided by Biogen, or by clicking on the  identifying numbers given above for each study.

Biogen also released information about an earlier study, called PRIME. This ongoing Phase 1b study is focusing on the safety, tolerability, drug activity in the body, and clinical effects of aducanumab in patients with probable or mild AD.

A research report based on the trial, “The antibody aducanumab reduces Abeta plaques in Alzheimer’s disease,” was recently published in the journal Nature.

In the study, participants were given either placebo or aducanumab at 1, 3, 6 and 10 mg/kg. The drug induced improvements in clinical measurements of cognition and memory, and brain amyloid plaques decreased and were almost completely gone in the group that received the highest dose of the medication.

PRIME also includes an extension,  after the study’s one year, offered to those patients given placebo.

According to Biogen, data from PRIME support the study design of the ENGAGE and EMERGE studies. Biogen plans to release additional information about PRIME at upcoming medical conferences.

Biogen developed aducanumab (BIIB037) for the treatment of early AD. It is a human recombinant monoclonal antibody identified based on known information about B-cells (immune system cells) that were collected from healthy elderly people. The company collaborated with Neurimmune, using technology called Reverse Translational Medicine. Biogen licensed aducanumab from Neurimmune as part of a collaborative agreement.