Opicinumab
Opicinumab (BIIB033) is a fully human monoclonal antibody designed for the treatment of multiple sclerosis, acute optic neuritis (AON), and other associated demyelinating diseases.[2] Some Phase II clinical trials have been carried out, but preliminary results indicate that primary study endpoints were not met and that opicinumab exhibits unexpected dose-response relationships.[6] The completed Phase II trial, dubbed RENEW by Biogen, studied the potential clinical efficacy of opicinumab in treating AON, more specifically in repairing damage done to the optic nerve.[1][7] The study successfully reached its primary endpoint and showed a 34 percent partial recovery of optic nerve latency, a measure of the time of conduction from the retina to the visual cortex.[1] The second completed Phase II clinical trial for opicinumab, called SYNERGY by Biogen, concluded in March 2016 but failed to reach its primary endpoint, which was an integrated measure of several MS progression and disability markers: ambulation, extremity functionality, cognition, and other typical indicators of MS.[1][9] Results from the study also showed highly unanticipated dose-response relationships in the MS patient population that will likely require further clinical trials to investigate satisfactorily.