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Friday, May 8, 2015

The Monoclonal Antibody Anti-LINGO-1 Is Shown to Repair Damaged Myelin in Acute Optic Neuritis

Published in Neurology
News · April 15, 2015

April 14, 2015—Washington, DC—
An experimental monoclonal antibody has been shown to remyelinate in a phase 2 trial. This first demonstration of neural damage repair in a condition linked to multiple sclerosis reported by Diego Cadavid, MD, of Biogen, Cambridge, Massachusetts, at the American Academy of Neurology 67th Annual Meeting in Washington, DC, from April 18 - 25.
Acute optic neuritis is a common and often presenting feature of multiple sclerosis, and attacks can lead to persistent visual impairment through neuroaxonal damage in the retina and optic nerve. Acute optic neuritis typically affects one eye and is characterized by inflammation, neural fiber damage, and loss of myelin within the optic nerve. It is estimated that about half of individuals who suffer acute optic neuritis will later develop multiple sclerosis. As with other relapses of multiple sclerosis, corticosteroids hasten recovery, but do not improve its final outcome. Hence there is an unmet need for neuroprotective therapy to prevent residual disability from relapses.
Dr. Cadavid explained that the RENEW trial of BIIB033, a fully human anti-LINGO-1, was conducted in patients who had a first incident of acute optic neuritis. LINGO is a protein in neurons and cells that synthesize myelin. Blocking this protein with BIIB033 has been shown to promote myelin repair in animal models and was well tolerated in phase 1 studies.
RENEW was a randomized, double-blind, placebo-controlled, parallel-group study. Subjects (age 18 to 50 years) completed treatment with high-dose steroids and were then randomized 1:1 to 100 mg/kg BIIB033 IV or placebo once every 4 weeks (six doses total) and followed to week 32.
Remyelination was evaluated by recovery of optic nerve conduction latency using full-field visual evoked potential and compared with the unaffected fellow eye at baseline. Neuro-protection was studied by measuring the thickness of the retinal nerve fiber layer and ganglion cell layer using spectral-domain optical coherence tomography, and change in low-contrast letter acuity. Safety and tolerability were also evaluated.
Eighty-two subjects received BIIB033 (intent-to-treat, n=41; per-protocol, n=33) or placebo (intent-to-treat, n=41; per-protocol, n=36). In the per-protocol population, BIIB033-treated patients showed a significantly improved average difference in latency recovery vs placebo: 7.55 msec at 24 weeks (ANCOVA, P = 0.05) and 9.13 msec (mixed-model repeated measures, P = 0.01) at 32 weeks.



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