Phase 3 Trial Update of BG-12 for Multiple Sclerosis
Biogen Idec announced data from CONFIRM, the second Phase 3 clinical trial of oral BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS).
The CONFIRM (Comparator and an Oral Fumarate in RRMS) clinical trial was a global, randomized, double-blind, placebo-controlled, dose-comparison study to determine the efficacy and safety of BG-12 and enrolled 1,430 people with RRMS. The study evaluated two dose regimens of BG-12, 240mg twice a day (BID) and 240mg three times a day (TID), as well as a reference comparator of glatiramer acetate (GA; 20mg subcutaneous daily injection [Copaxone; Teva Neuroscience]). Both BG-12 and GA groups were evaluated vs. placebo.
BG-12 met the study's primary endpoint by significantly reducing annualized relapse rate (ARR) by 44% for BID and by 51% for TID (P<0.0001 for both) compared to placebo over two years. GA reduced ARR by 29% (P=0.0128) compared to placebo over two years. BG-12 met the study's secondary relapse endpoint by significantly reducing the proportion of patients who relapsed at two years by 34% for BID (P=0.0020) and by 45% for TID (P<0.0001) compared to placebo. GA provided a 29% reduction (P=0.0097) in the proportion of relapsing patients compared to placebo over the same time period. BG-12 also met magnetic resonance imaging (MRI) endpoints in a cohort of patients, demonstrating a significant effect on MS brain lesions. Reductions in new brain lesion counts were evident within the first year of treatment and were sustained throughout the study.
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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