Biogen Idec (BIIB) Reports BG-12 Met Primary Endpoint in Two Phase 2s

Biogen Idec (Nasdaq: BIIB) reports positive top-line results from CONFIRM, the second of two pivotal Phase 3 clinical trials designed to evaluate the investigational oral compound BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered either twice a day (BID) or three times a day (TID), demonstrated significant efficacy and favorable safety and tolerability profiles. Further analyses of the CONFIRM study are ongoing, and the company anticipates presenting detailed data at a future medical meeting.

BG-12 met the CONFIRM study’s primary endpoint by significantly reducing annualized relapse rate (ARR) by 44 percent for BID (p< 0.0001) and by 51 percent for TID (p< 0.0001) versus placebo at two years. The CONFIRM study’s reference comparator, glatiramer acetate (GA; 20 mg subcutaneous daily injection), reduced the ARR by 29 percent (p< 0.02) compared with placebo at two years.

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