Biogen today said it will continue clinical development of opicinumab (anti-LINGO-1) despite the multiple sclerosis (MS) candidate missing its primary endpoint in the Phase II SYNERGY trial, citing data it said showed signs of possible efficacy.

Opicinumab  is a fully human monoclonal antibody being developed as a potential neuroreparative therapy in people with relapsing forms of MS.

Biogen acknowledged that opicinumab missed SYNERGY’s primary endpoint, a multicomponent measure evaluating improvement of physical function, cognitive function, and disability. Opicinumab also missed the trial’s secondary efficacy endpoint, which assessing the slowing of disability progression.

But the company said its data also showed evidence of a clinical effect with a complex, unexpected dose–response and added that SYNERGY results will be presented “at future medical meetings.”

“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,” Alfred Sandrock, M.D., Ph.D., Biogen evp and CMO, 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.”

SYNERGY’s primary endpoint was a measure evaluating the number of study participants who experienced 3-month confirmed improvement of ambulation (Timed 25-Foot Walk), upper extremity function (9-Hole Peg Test), cognition (3-Second Paced Auditory Serial Addition Test), and standard measures of physical disability (Expanded Disability Status Scale).

Secondary endpoints of the trial measured slowing of progression on the same components, as well as the safety and pharmacokinetics (PK) of opicinumab. According to Biogen, opicinumab (formerly BIIB033) showed a linear, well-behaved PK profile over the studied dose range and was generally well-tolerated with a safety profile consistent with that seen in prior studies.

SYNERGY was a randomized, double-blind, placebo-controlled, dose-ranging Phase II study designed to assess opicinumab among 418 participants with relapsing forms of MS—both relapsing-remitting and secondary progressive—when used concurrently with Biogen’s Avonex® (interferon beta-1a), indicated for patients with relapsing MS, over 72 weeks.








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