Confirm study shows that oral BG-12 significantly reduces annualized relapse rate.
Biogen Idec reported positive topline data from a second Phase III study with its oral drug candidate BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis (RRMS). Results from the Confirm study follow less than a week after Biogen Idec reported positive results from the first Phase III BG-12 study, Define.
The Confirm trial showed that treating RRMS patients using either twice- or thrice-daily oral BG-12 reduced the annualized relapse rate (ARR) by 44% and 51%, respectively, compared with placebo. Treatment with the comparator reference drug, subcutaneous glatiramer acetate, resulted in a 29% reduction in ARR at two years.
BG-12 therapy in addition met all secondary relapse and MRI endpoints. “We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients,” remarks Doug Williams, Ph.D., Biogen Idec executive vp for R&D. “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.”
