Biogen BIIB announced positive new data from the phase II RENEW study on anti-LINGO-1 for acute optic neuritis (AON). The company intends to present data from the study at the annual meeting of the American Academy of Neurology.
Results revealed statistically significant improvement in recovery of optic nerve conduction latency, as measured by full-field visual evoked potential (FF-VEP), in patients treated with anti-LINGO-1 at the last study visit (week 32) as compared to placebo. Also results from a sub study of multifocal VEP are similar to that of findings from the FF-VEP.
Earlier in the year, Biogen revealed positive top-line results from the RENEW study. Results revealed that patients treated with anti-LINGO-1 showed biological repair of their visual system. Anti-LINGO-1 was well tolerated among the patients. Biogen said these results were the first to show evidence of biological repair in the central nervous system following an acute inflammatory injury by facilitating remyelination.
Biogen is currently evaluating anti-LINGO-1 in a phase II, double-blind, placebo-controlled, randomized, 22-month long dose-range finding study (SYNERGY) in patients suffering from relapsing forms of multiple sclerosis (MS) including secondary progressive MS.
In a separate press release, Biogen announced that the U.S. Patent Trial and Appeal Board have declared interference between Forward Pharma’s FWP patent application 11/576,871 and Biogen’s issued patent 8,399,514. Both the patents claim methods of treating MS with dimethyl fumarate (480 mg per day).
If Forward Pharma prevails in the interference its patent application will be issued and subsequently the claims of Biogen’s patent will be cancelled. Biogen reported Tecfidera (dimethyl fumarate) worldwide sales of over $2.9 billion in 2014.