Phase 3 Study Update of BG-12 for Multiple Sclerosis

Biogen Idec announced new data from Phase 3 studies evaluating oral BG-12 (dimethyl fumarate), which provide further evidence supporting its clinical and radiological effects in people with relapsing-remitting multiple sclerosis (RRMS).

DEFINE and CONFIRM were randomized, double-blind studies that compared the efficacy and safety of dimethyl fumarate 240mg, administered twice daily (BID) or three times daily (TID), to placebo over two years. CONFIRM also included a reference comparator of glatiramer acetate 20mg subcutaneous daily injection (Copaxone; Teva Neuroscience). 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 vs. placebo on relapse, progression and MRI outcomes.

Analyses of the pooled clinical efficacy results of DEFINE and CONFIRM show that treatment with dimethyl fumarate led to significant reductions in MS relapses and disease progression. At two years compared to placebo, dimethyl fumarate significantly reduced:

  • Annualized relapse rate (ARR) by 49% for both BID and TID (P<0.0001 for both)
  • Proportion of patients who relapsed by 43% for BID and 47% for TID (P<0.0001 for both)
  • Risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 32% for BID (P=0.0034) and 30% for TID (P=0.0059)

In MRI cohorts from DEFINE and CONFIRM, treatment with dimethyl fumarate significantly improved MRI outcomes over two years compared to placebo by reducing:

  • Mean number of new or newly enlarging T2-hyperintense lesions by 78% for BID and 73% for TID (P<0.0001 for both)
  • Mean number of new non-enhancing T1-hypointense lesions by 65% for BID and 64% for TID (P<0.0001 for both)
  • Odds of having a greater number of gadolinium-enhancing (Gd+) lesions by 83% for BID and 70% for TID (P<0.0001 for both)

Dimethyl fumarate, also known as BG-12, is an investigational oral therapy in late-stage clinical development for the treatment of RRMS, the most common form of MS. Dimethyl fumarate has experimentally demonstrated activation of the Nrf-2 pathway.

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