Biogen Idec’s oral multiple sclerosis candidate, BG-12 (dimethyl fumarate), met its primary endpoint in the first of two Phase III pivotal trials in patients with relapsing-remitting disease. The placebo-controlled Define study showed that treatment with BG-12 twice or three times daily led to a significant reduction in the two-year relapse rate. Both treatment regimens also met all secondary endpoints, including reduced annualized relapse rate, the number of new or newly enlarging T2 hyperintense lesions and new GD+ lesions, and the rate of disability progression measured by the expanded disability severity scale at two years. The overall incidence of adverse events and serious adverse events was similar among the placebo and both BG-12 treatment groups.
“The significant clinical responses seen in the Define study represent an important step forward in the development of BG-12 for multiple sclerosis,” notes Douglas Williams, Ph.D., executive vp for R&D at Biogen Idec.
A second Phase III study, Confirm, is currently under way in patients with relapsing-remitting MS. The study is evaluating BG-12 and the active reference comparator glatiramer acetate against placebo. Endpoints include clinical relapse, MRI measures of MS, and progression of disability. Results from Confirm are expected during the second half of 2011.