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Study: Anti-LINGO-1 shows evidence of repair of visual system in acute optic neuritis
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Anti-LINGO-1, an investigational monoclonal antibody, showed evidence of biological repair of the visual system in the phase 2 acute optic neuritis RENEW trial, Biogen Idec announced in a press release.
There was improvement in the recovery of optic nerve latency, the primary endpoint of the study. However, there was no effect on secondary endpoints, including change in thickness of retinal layers and visual function, according to the top-line results.
The randomized, double-masked, placebo-controlled RENEW trial examined anti-LINGO-1’s ability to enable repair of an optic nerve lesion through axonal remyelination after a first episode of acute optic neuritis, the release said. It measured the latency of nerve conduction between the retina and the visual cortex using full-field visual evoked potential.
Eighty-two patients were enrolled at 33 sites in Europe, Canada and Australia and received six intravenous infusions of 100 mg/kg of anti-LINGO-1 or placebo every 4 weeks.
At week 24, there was a 34% improvement in the recovery of optic nerve latency compared with placebo in the per-protocol population. The analysis did not reach statistical significance but showed a positive trend.
Anti-LINGO-1 was generally well tolerated, but two patients had hypersensitivity reactions around the time of anti-LINGO-1 infusion and one patient experienced an asymptomatic elevation in liver transaminases that resolved after drug discontinuation, the release said.