BG-12 2nd trial is positive. Beats Copaxone with ease.
Biogen Idec (NASDAQ:BIIB - News) announced positive top-line results from CONFIRM, the second of two pivotal Phase 3 clinical trials designed to evaluate the investigational oral compound 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), demonstrated significant efficacy and favorable safety and tolerability profiles. Further analyses of the CONFIRM study are ongoing, and the company anticipates presenting detailed data at a future medical meeting.
BG-12 met the CONFIRM study’s primary endpoint by significantly reducing annualized relapse rate (ARR) by 44 percent for BID (p< 0.0001) and by 51 percent for TID (p< 0.0001) versus placebo at two years. The CONFIRM study’s reference comparator, glatiramer acetate (GA; 20 mg subcutaneous daily injection), reduced the ARR by 29 percent (p< 0.02) compared with placebo at two years.
In addition to significantly reducing ARR, BG-12 met all secondary relapse and MRI endpoints for both dose regimens. Results for the BG-12 and GA treatment groups at two years compared with placebo included:
BG-12 reduced the number of new or newly enlarging T2-hyperintense lesions by 71 percent for BID (p<0.0001) and by 73 percent for TID (p<0.0001), while GA provided a 54 percent (p<0.0001) reduction.
BG-12 reduced new T1-hypointense lesions by 57 percent for BID (p<0.0001) and by 65 percent for TID (p<0.0001), while GA provided a 41 percent (p<0.003) reduction.
BG-12 reduced the proportion of patients who relapsed by 34 percent for BID (p<0.003) and by 45 percent for TID (p<0.0001), while GA provided a 29 percent (p<0.01) reduction.
Initial results showed that BG-12 reduced 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS) by 21 percent for BID and 24 percent for TID at two years compared to placebo, and GA reduced confirmed disability progression by 7 percent. While these results were not statistically significant, they may be attributable to the unexpectedly low rate of disease progression in the placebo group, which was approximately half of what has been seen in clinical trials of approved and experimental multiple sclerosis (MS) therapies. Further analyses of this endpoint are underway.
“We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients,” said Doug Williams, Ph.D., Biogen Idec’s Executive Vice President of Research and Development. “We are gratified by these strong efficacy and safety results, which, when combined with BG-12’s oral route of administration, position it as a potentially important MS therapy. We are working aggressively to prepare our regulatory submissions with the goal of making BG-12 available to MS patients as quickly as possible.”
