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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
Biogen Idec’s investigational monoclonal antibody met its primary endpoints in a recent Phase II for the treatment of acute optic neuritis.
Biogen Idec announced on Jan. 8, 2015 that its anti-LINGO-1 medication for the treatment of acute optic neuritis (AON) demonstrated evidence of biological repair in the eyes of those suffering from inflammation of the optic nerve. Although the anti-LINGO-1 showed an improvement in optic nerve conduction between the visual cortex and the brain-the study’s primary endpoint-it showed no effect on secondary endpoints, which focused on the improvement of thickness of the retinal layers and visual acuity.
Although the study met its primary endpoints, and there was a 34% improvement in eye nerve conduction for those who completed the study, when study dropouts were included, the results were no longer significant, reportsForbes’ Matthew Herper. Evercore ISI analyst Mark Schoenebaum says the data are “encouraging, but certainly not definitive.”
Biogen Idec discovered anti-LINGO in multiple animal models of demyelination. The monoclonal antibody-based drug works by blocking LINGO-1, a protein expressed in the central nervous system that is known to negatively regulate axonal myelination and regeneration. According to the company, LINGO-1 promotes myelin repair and regeneration.
Acute optic neuritis is characterized by loss of the myelin sheath surrounding the optic nerve and axonal injury. Because optic neuritis is highly associated with relapsing forms of multiple sclerosis (MS), and Biogen is currently testing the drug for this indication in a Phase II trial dubbed SYNERGY, analysts believe it could be promising therapy for progressive forms of MS. Data from the SYNERGY trial are anticipated in 2016.