Phase II study of opicinumab in MS misses primary endpoint
Posted: 7 June 2016 | | 1 comment
The primary endpoint primary endpoint was a multicomponent measure evaluating improvement of physical function, cognitive function, and disability…
Biogen has reported top-line results from the Phase II SYNERGY study evaluating opicinumab (anti-LINGO-1) in people with relapsing forms of multiple sclerosis (RMS).
In the study, opicinumab missed the primary endpoint, a multicomponent measure evaluating improvement of physical function, cognitive function, and disability. However, evidence of a clinical effect with a complex, unexpected dose-response was observed.
“It is only through taking thoughtful, calculated risks that we can bring major advances to patients,” commented Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “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.”
The therapy 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. Opicinumab 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.