Biogen said it will continue clinical development of opicinumab (anti-LINGO-1) even though the multiple sclerosis (MS) candidate missed its primary endpoint in a phase II trial.
The primary endpoint was a multicomponent measure assessing enhancement of physical function, cognitive function, and disability.
Opicinumab also did not meet the secondary efficacy endpoint in the Phase 2 Synergy study, which assessed the slowing of disability progression.
Biogen has however observed evidence of a clinical effect with a complex, unexpected dose-response.
The phase 2 study evaluated the impact of opicinumab in 418 participants with relapsing forms of MS over 72 weeks.
Biogen executive vice president and chief medical officer Alfred Sandrock said: “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.”
Biogen said opicinumab is a neurologic protein that is involved in the development of myelin.
In patients with MS, opicinumab could inhibit myelin growth when it binds with its normal receptor.
Data indicates that the antibody anti-LINGO-1 may block this process, potentially enabling for the re-myelination and restoration of nerve communication in MS patients.
Published 08 June 2016