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MS Drug Opicinumab Misses Primary Endpoint in Mid-Stage Trial
Biogen has reported results from the phase 2 SYNERGY study evaluating opicinumab (anti-LINGO-1), an investigational, fully human monoclonal antibody being developed as a potential neuroreparative therapy in patients with relapsing forms of multiple sclerosis (RMS). Opicinumab missed the trial’s primary endpoint, a multicomponent measure evaluating improvements in physical function, cognitive function, and disability.
Opicinumab also did not meet the study’s secondary efficacy endpoint, which evaluated the slowing of disability progression.
The SYNERGY trial was a 72-week, randomized, double-blind, placebo-controlled, dose-ranging study that evaluated opicinumab in 418 participants with RMS (both relapsing-remitting and secondary progressive). The primary endpoint was a multicomponent measure evaluating the number of study participants who experienced three-month confirmed improvement of ambulation (timed 25-foot walk), upper extremity function (nine-hole peg test), cognition (three-second Paced Auditory Serial Addition Test), and standard measures of physical disability (Expanded Disability Status Scale). Secondary endpoints measured slowing of progression on the same components, as well as the safety and pharmacokinetics of opicinumab. Statistical testing assessed the dose-response trend based on the primary or secondary endpoint.
Opicinumab was administered intravenously every four weeks at a dose of 3 mg/kg, 10 mg/kg, 30 mg/kg, or 100 mg/kg. All subjects received concurrent treatment with interferon beta-1a intramuscular injection (30 mcg once weekly).
Source: Biogen; June 7, 2016.