Biogen Idec announced positive results from its Phase 3 study of BG-12 (dimethyl fumarate) for the treatment of relapsing-remitting multiple sclerosis (RRMS). This global, randomized, double-blind, placebo-controlled, dose-comparison study was designed to determine the efficacy and safety of BG-12 in people with RRMS. The results showed that patients taking 240mg of BG-12 met the primary endpoint, demonstrating a statistically significant reduction (p<0.0001) in the proportion of patients with RRMS who relapsed at two years compared with placebo. Secondary endpoints were achieved as well, providing statistically significant reduction in annualized relapse rate, in the number of new or newly enlarging T2 hyperintense lesions, in new gadolinium-enhancing (Gd+) lesions, and in the rate of disability progression.
BG-12 is an oral, small molecule immune modulator.
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