Biogen Stumbles Over Missed Mid-Stage Results

Health and Healthcare

Published: June 7, 2016 11:10 am

Last Updated: January 13, 2020 7:06 am

Shares of Biogen Inc. (NASDAQ: BIIB) slumped early in Tuesday’s session following the release of less-than-favorable top-line results from its mid-stage clinical study. This was part of the company’s Synergy study evaluating opicinumab, an investigational, fully human monoclonal antibody being developed as a potential neuroreparative therapy in people with relapsing forms of multiple sclerosis.

In the study, opicinumab missed the primary endpoint, a measure evaluating improvement of physical function, cognitive function and disability. However, evidence of a clinical effect with a complex, unexpected dose-response was observed.

Again more bad news, opicinumab also did not meet the secondary efficacy endpoint in Synergy, which evaluated the slowing of disability progression. Safety and pharmacokinetics (PK) were also assessed as secondary endpoints.

The drug candidate was generally well-tolerated and the safety profile was consistent with what has been observed in prior studies. Opicinumab showed a linear, well-behaved PK profile over the studied dose range. Synergy results will be presented at future medical meetings.

Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen, commented:

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 analyze the results to inform the design of our next study.

So far in 2016, Biogen has underperformed the broad markets, with the stock down over 5% (excluding Tuesday’s move). Over the past 52 weeks, the stock is down over 25%.

Shares of Biogen were trading down about 13% at $252.40 Tuesday morning, with a consensus analyst price target of $345.50 and a 52-week trading range of $242.07 to $420.99.

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