Phase 3 Study Updates of BG-12 for Multiple Sclerosis

Biogen Idec announced detailed results from its two pivotal clinical trials evaluating oral BG-12 (dimethyl fumarate) for the treatment of multiple sclerosis (MS).

Data from the Phase 3 DEFINE and CONFIRM studies show that dimethyl fumarate (240mg), administered twice daily (BID) or three times daily (TID), demonstrated significant and clinically meaningful reductions in MS relapses and brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS) compared to placebo, as well as showed benefit in slowing the progression of the disease.

DEFINE was a two-year global study that evaluated dimethyl fumarate (240mg, BID or TID) compared to placebo in people with RRMS. Results showed that both dimethyl fumarate BID and TID met the study’s primary endpoint by significantly reducing the proportion of patients who relapsed by 49% and 50% (P<0.0001 for both), respectively, at two years compared to placebo. Both dosing regimens also met all secondary endpoints in the study.

Like DEFINE, CONFIRM was a two-year global clinical trial that investigated dimethyl fumarate (240mg, BID or TID) vs. placebo in people with RRMS. The study also included an active reference comparator of glatiramer acetate (GA; 20mg subcutaneous daily injection [Copaxone; Teva Neuroscience) vs. placebo. Results showed that both dimethyl fumarate BID and TID met the study’s primary endpoint by significantly reducing annualized relapse rate (ARR) by 44% and 51% (P<0.0001 for both), respectively, vs. placebo at two years. In addition, both dosing regimens of dimethyl fumarate met all secondary relapse and magnetic resonance imaging (MRI) endpoints in the study. While not statistically significant, dimethyl fumarate showed a clinically meaningful reduction in 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).

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

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