-240 mg of BG-12 Administered Either Twice or Three Times Daily Demonstrated Significant Clinical Effects-
WESTON, Mass., Oct 21, 2011 (BUSINESS WIRE) — Today Biogen Idec announced positive data from the Phase 3 DEFINE clinical trial of oral BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered either twice a day (BID) or three times a day (TID), significantly reduced the proportion of patients who relapsed by 49 percent and 50 percent, respectively, at two years compared with placebo. Detailed data from DEFINE will be presented at the 5th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in Amsterdam, including a platform presentation on Friday, October 21, 2011 at 9:30 a.m. CEST.
“The significant clinical and radiological responses in DEFINE are further evidence that BG-12 may become an oral therapy of choice for MS patients,” said Doug Williams, Ph.D., Biogen Idec’s Executive Vice President of Research and Development. “Results from our second Phase 3 trial, CONFIRM, will provide additional insight into BG-12’s profile, as well as a comprehensive data set to further discussions with regulatory authorities. We anticipate releasing top-line data from CONFIRM later this year.”
DEFINE was the first of two Phase 3 clinical trials designed to determine the efficacy and safety of BG-12 in people with RRMS. Both BG-12 BID and TID met the primary and all secondary endpoints in the study. In addition to demonstrating a significant reduction in the proportion of patients who relapsed, BG-12 significantly reduced the annualized relapse rate (ARR) and the risk of disability progression as measured by the Expanded Disability Status Scale (EDSS) at two years compared to patients on placebo.
— BG-12 reduced the risk of relapse by 49 percent in the BID group (HR 0.51; 95% confidence interval [CI] 0.40, 0.66; p<0.0001) and by 50 percent in the TID group (HR 0.50; 95% CI 0.39, 0.65; p<0.0001).
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