It had been hoped that Biogen’s experimental drug opicinumab would be able to repair mylin. As those of us who live with Multiple Sclerosis know all too well, mylin is sort of an insulator to our nerves. MS destroys mylin and, in doing so, short circuits our nervous system.
Biogen announced today that Phase 2 of its opicinumab trial, named SYNERGY, failed to meet its primary goal of improving physical and cognitive function and disability. It also failed to meet a secondary goal of slowing the progress of the disease.
In a news release, Biogen’s Chief Medical Officer, Alfred Sandrock, M.D., Ph.D., says: “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.”
Dr. Sandrock says the test data is “complex” and Biogen scientists continue to analyze the results to help in the design of the company’s next study.
SYNERGY was a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study that evaluated the impact of opicinumab among 418 participants with relapsing forms of multiple sclerosis (both relapsing-remitting and secondary progressive) over 72 weeks.