Phase 3 Study of BG-12 for Relapsing-Remitting Multiple Sclerosis

Biogen Idec announced positive data from its Phase 3 DEFINE study of BG-12 (dimethyl fumarate) for the treatment of people with relapsing-remitting multiple sclerosis (RRMS). DEFINE was a global, randomized, double-blind, placebo-controlled, dose-comparison study to determine the efficacy and safety of BG-12 in people with RRMS. The primary objective was to determine if BG-12 is effective in reducing the proportion of relapsing patients at two years. Secondary endpoints included annualized relapse rate (ARR), disability progression as measured by the Expanded Disability Status Scale (EDSS), and, in a cohort of sites, the number of new or newly enlarging T2 hyperintense lesions and the number of Gd+ lesions as measured by brain MRI.

Results of the study demonstrated that BG-12 reduced the risk of relapse by 49% in the twice daily group (HR 0.51; 95% confidence interval [CI] 0.40, 0.66; P<0.0001) and by 50% in the three times daily group (HR 0.50; 95% CI 0.39, 0.65; P<0.0001). BG-12 twice daily reduced the ARR by 53%, while BG-12 three times daily reduced the ARR by 48% (P<0.0001 for both). BG-12 twice daily reduced the risk of disability progression by 38% (HR 0.62; 95% CI 0.44, 0.87; P=0.005), while BG-12 three times daily reduced this risk by 34% (HR 0.66; 95% CI 0.48, 0.92; P=0.0128).

BG-12 (dimethyl fumarate) is an investigational oral therapy known to activate the Nrf-2 pathway. Research suggests that BG-12 has the potential to reduce the activity and impact of inflammatory cells on the Central Nervous System (CNS) and induce direct cytoprotective responses in CNS cells. These effects may enhance the CNS cells' ability to mitigate the toxic inflammatory and oxidative stress that plays a role in MS pathophysiology. 

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