Biogen’s ($BIIB) multiple sclerosis hopeful opicinumab has missed the primary and secondary efficacy endpoints in a Phase II trial. But, with the Big Biotech spotting a possible positive nugget amid the wreckage, it is digging into the data set rather than writing the program off, raising the prospect that it will continue to chase an elusive success.
At the top line, the trial is a clear failure. Biogen set out to see if its monoclonal antibody opicinumab could have an effect on a multicomponent primary endpoint designed to assess ambulation, upper extremity function and physical disability in patients with relapsing forms of multiple sclerosis. Opicinumab failed to outperform placebo in this regard. A secondary efficacy endpoint intended to evaluate the slowing of disability progression also came up negative.
Despite these setbacks, Biogen has seen something in the data that could compel it to continue with development of the antibody. “While we missed the primary endpoint, the SYNERGY study results suggest evidence of a clinical effect of opicinumab,” Biogen CMO Alfred Sandrock said in a statement. “Due to the complex nature of the data set, we continue to analyze the results to inform the design of our next study.”
In a release to unveil the top-line results, Biogen pointed to a “complex, unexpected dose-response” as a reason not to write the drug off yet. Such a cause for encouragement in an otherwise negative data set could ultimately prove to be the worst of all possible outcomes for Biogen if it encourages the company to embark on further clinical trials that ultimately deliver more negative data.
Whatever path Biogen takes now, it will embark on it from a weakened position. Shares in the company dropped 9% in premarket trading--a decline that amounts to around the loss of $6 billion from its market cap. And, with the latest setback adding to other disappointments for Biogen and its investors, pressure is now mounting on the company to make changes.
- read the statement