Biogen Reports New Anti-LINGO-1 Phase 2 Acute Optic Neuritis Data Demonstrating Neurological Repair
Today, Biogen (NASDAQ: BIIB) announced detailed results from the Phase 2 RENEW study of anti-LINGO-1 in acute optic neuritis (AON) – the first clinical study to demonstrate remyelination (the formation of new myelin on axons) following an inflammatory injury in humans. These data will be presented at the 67th Annual Meeting of the American Academy of Neurology (AAN) in Washington, DC, next week.
The new data demonstrate a statistically significant improvement in recovery of optic nerve conduction latency (time for a signal to travel from the retina to the brain's visual cortex), as measured by the primary endpoint full-field visual evoked potential (FF-VEP), among anti-LINGO-1-treated participants at the last study visit (week 32), as compared to placebo. Results from a sub study of multifocal VEP (mfVEP) are consistent with the FF-VEP findings. These data supplement the top-line, 24-week RENEW results reported by Biogen in January 2015.
"RENEW is the first study to show repair of the human central nervous system (CNS) through remyelination, and the results support our ongoing development of this molecule," said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen. "We believe the anti-LINGO-1 data point toward a potential new approach to treating demyelinating diseases, and we look forward to the ongoing Phase 2 SYNERGY study results to further clarify the potential of this investigational therapy in MS."
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