Positive Early-Stage Clinical Data for Biogen Alzheimer’s Drug

Biogen Idec has announced plans to move their investigational Alzheimer’s drug into Phase III trials, after receiving promising early-stage clinical data.

Douglas Williams, Biogen Idec’s R&D chief, noted that in the interim analysis of their Phase Ib clinical trial, aducanumab (also known as BIIB037) showed a significant reduction in the beta-amyloid protein in early-stage patients.  After 54 weeks, results showed that patients exhibited statistically significant cognitive improvements.

Williams added that there are “lots of caveats, obviously, because we’re still early in the clinical program, but encouraging enough data to really have us pull the trigger on moving forward aggressively to plan for Phase III.”

Aducanumab is the cornerstone of an Alzheimer’s alliance established with Eisai earlier this year, after Biogen acquired the treatment from Neurimmune Therapeutics in 2007.  After the announcement, shares in Biogen jumped nearly 7%.

It is still early days for testing the treatment, and Biogen has not yet given a timeline on when the Phase III clinical studies will begin, but the results have received a positive response.

RBC Capital Markets analyst, Michael Yee, commented that the results “will add to the mounting evidence that these drugs ‘might’ work in earlier patients, rather than all the historical failures in moderate/sicker patients where the drugs were first tested.”

Nonetheless, Yee noted that early-stage success followed by late-stage failure has been seen before.

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