CONFIRM trial positive for BG-12 in Multiple Sclerosis

Biogen announced positive top-line results from CONFIRM, the second of two pivotal Phase III clinical trials designed to evaluate the oral compound BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS).Th earlier trial was DEFINE study. 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. 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.