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By Marie PowersNews Editor
Top-line findings for
Biogen Inc.’s anti-LINGO-1 monoclonal antibody candidate,
BIIB033, that were released earlier this year gained a bit more credibility when additional data were disclosed today in advance of the company’s presentations next week at the American Academy of Neurology’s (AAN) 67th Annual Meeting in Washington.
The data, from five abstracts that Biogen researchers will present at AAN, showed additional evidence from studies in acute optic neuritis (AON) that the investigational therapy may repair myelin in humans. The AON data are designed to advance the scientific thesis on anti-LINGO-1, which the company also is testing in multiple sclerosis (MS).
The randomized, double-blind, placebo-controlled phase II RENEW trial evaluated anti-LINGO-1’s ability to enable repair of an optic nerve lesion through axonal remyelination after the onset of a first episode of AON. The study enrolled 82 patients following their first incident of AON – a disease that typically affects one eye and is characterized by inflammation, damage to the nerve fibers and loss of myelin within the optic nerve – across 33 sites in Europe, Canada and Australia. Patients received six intravenous infusions of 100 mg/kg anti-LINGO-1 or placebo every four weeks.
AON was selected as an initial indication for the drug because an estimated 50 percent of those affected with the eye condition later develop MS.
RENEW examined the effects on remyelination by measuring the latency of nerve conduction between the retina and the visual cortex in the brain using full field visual evoked potential, or FF-VEP. In January, Biogen reported that patients treated with BIIB033 showed improvement in recovery of optic nerve latency, or the time for a signal to travel from the retina to the visual cortex, over 24 weeks, providing evidence of biological repair to the visual system. However, the results – a 34 percent improvement (p = 0.0504) in the recovery of optic nerve latency compared to placebo – were not statistically significant.
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