CAMBRIDGE, Mass. (TheStreet) -- Biogen Idec reported "positive" study results Thursday on its closely followed nerve repair drug anti-LINGO-1, although the purported benefit requires much eye squinting to see. Investor expectations for the anti-LINGO-1 data in patients with acute optic neuritis were on the low side, so expect Wall Street to expend considerable time interpreting the mixed bag of actual results produced by Biogen's most important pipeline drug candidate. Biogen share were up 2% to $360.95 in pre-market trading. The phase II study enrolled 80 patients with acute optic neuritis, a disease in which inflammation and damage to the optic nerve linking the eye to the brain causes pain and vision loss. The patients were to treatment with six doses of anti-LINGO-1 or six matching placebo doses over 20 weeks. At 24 weeks, the patients in both arms of the study were evaluated and compared. The primary efficacy endpoint was the change in nerve conduction velocity (NCV) -- a measurement of the speed at which electrical impulses travel through the nerve. On this NCV measure, anti-LINGO-1 demonstrated a 34% improvement compared to placebo that was just barely statistically significant. However, this was a modified analysis which excluded patients who discontinued from the study prematurely. When all patients were analyzed, there was a "positive trend" in NCV improvement favoring anti-LINGO-1 but the benefit wasn't statistically significant, Biogen said. The key secondary endpoints of the study were designed to see if treatment with anti-LINGO-1 could produce positive changes in nerve thickness and visual acuity. On both measures, however, anti-LINGO-1 failed to demonstrate any effect, Biogen said. "We believe the results are encouraging, as this is the first clinical trial to provide evidence of biological repair in the central nervous system by facilitating remyelination following an acute inflammatory injury," said Biogen Chief Medical Officer Alfred Sandrock, in a statement. Biogen is conducting a second, phase II study of anti-LINGO-1 in patients with multiple sclerosis. Results are expected next year. Biogen's anti-LINGO-1 antibody is a potential therapeutic game changer for chronic neuro-degenerative diseases like multiple sclerosis. The drug is designed to block the production of a protein known as LINGO-1, which when expressed in the central nervous system, leads to the degradation of the protective myelin sheath around nerve fibers. The breakdown or "demyelination" of nerve fibers interferes with the transmission of nerve impulses, leading to physical and cognitive disability. Biogen's existing multiple sclerosis drugs -- Avonex, Tysabri, Tecfidera, Plegridy -- all work by slowing down the demyelination of nerve fibers. If anti-LINGO-1 antibody can prevent the destructive LINGO-1 protein from being produced, nerve fibers in multiple sclerosis patients might be "remyelinated" and the damage caused by the disease reversed or eradicated altogether. This is a really big deal because no drug today has been shown to repair nerve fibers in multiple sclerosis patients.
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