Biogen has reported that its experimental treatment for relapsing forms of multiple sclerosis (MS), opicinumab (anti-LINGO-1), failed to meet its primary and secondary endpoints in the Phase 2 SYNERGY study.
The drug, a fully human monoclonal antibody intended as neuroreparative therapy, did however show evidence of a clinical effect through an unexpected dose-response.
The SYNERGY study was a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study in 418 patients with relapsing-remitting and secondary progressive MS. Opicinumab missed the primary endpoint, a multi-component measure of improvement in physical function, cognitive function, and disability at 3 months. The drug also failed to show a slowing of disability progression, which was the secondary efficacy endpoint. The drug was generally well-tolerated and the safety profile was in line with what had been previously observed.
In another Phase 2 trial (RENEW), opicinumab showed improved latency recovery in patients with acute optic neuritis compared to placebo, however the drug had no effects on secondary endpoints, including change in thickness of the retinal layers or visual function.
“It is only through taking thoughtful, calculated risks that we can bring major advances to patients,” Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, said in a statement. “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.”
The company plans to release full results of SYNERGY at future medical meetings.