Today Biogen Idec (NASDAQ: BIIB) announced new data from studies evaluating oral BG-12 (dimethyl fumarate), which provide further evidence supporting its strong clinical and radiological effects in people with relapsing-remitting multiple sclerosis (RRMS) and reinforce its favorable safety profile seen to date. These data were presented at the 28
Congress of the European Committee for the Treatment and Research of Multiple Sclerosis (ECTRIMS) in Lyon, France.
In a pre-specified analysis of integrated, or pooled, data from the Phase 3 DEFINE and CONFIRM studies, dimethyl fumarate showed statistically significant and clinically relevant effects in reducing multiple sclerosis (MS) relapses and progression of disability, as well as reductions in magnetic resonance imaging (MRI) measures of disease activity. In addition, interim safety data from a Phase 3 extension study indicate that continued exposure to dimethyl fumarate did not result in any new or worsening safety signals, and that its safety and tolerability profiles were consistent with previous studies.
“These data provide additional insight into the positive efficacy and safety results from our Phase 3 studies, showing there is a consistent beneficial effect with dimethyl fumarate in reducing MS relapses, brain lesions and disability,” said Alfred Sandrock, M.D., Ph.D., senior vice president, Development Sciences and chief medical officer of Biogen Idec. “If approved, dimethyl fumarate may provide a broad range of MS patients with an effective therapy that offers the ease of oral administration and an acceptable tolerability profile.”
Analyses of Pooled Phase 3 Efficacy Results
DEFINE and CONFIRM were randomized, double-blind studies that compared the efficacy and safety of dimethyl fumarate 240 mg, administered twice daily (BID) or three times daily (TID), to placebo over two years. CONFIRM also included a reference comparator of glatiramer acetate (GA; 20 mg subcutaneous daily injection). A pooled analysis of the efficacy data from more than 2,300 patients in these two studies was performed in order to provide the medical community with a more precise estimate of dimethyl fumarate’s treatment effects versus placebo on relapse, progression and MRI outcomes.