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Biogen MS drug misses primary endpoint in Phase II trial

Published on 08/06/16 at 08:29am

Biogen has reported top-line results in the Phase II trial evaluating opicinumab (anti-Lingo-1) in relapsing forms of multiple sclerosis, with the drug failing to meet the primary endpoint.

The primary endpoint of the trial was a multicomponent measure evaluating improvement of physical function, cognitive function, and disability. It also failed to meet the secondary efficacy endpoint, which evaluated the slowing of disability progression. However, opicinumab was well-tolerated with a consistent safety profile with previous studies.

Biogen does point out, also, that there was evidence of a clinical effect with a complex, unexpected dose-response. Alfred Sandrock, chief medical officer at Biogen, says: “It is only through taking thoughtful, calculated risks that we can bring major advances to patients.

“Achieving repair of the human central nervous system through remyelination would be a substantial achievement, and while we missed the primary endpoint, the SYNERGY study results suggest evidence of a clinical effect of opicinumab. Due to the complex nature of the data set, we continue to analyse the results to inform the design of our next study.”

Shares at Biogen fell almost 9% upon the announcement of the news.

Sean Murray

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