BG-12: Additional Phase III data

Additional data from the double-blind, international Phase III DEFINE trial in >1,200 patients showed that twice-daily 240 mg oral BG-12 significantly reduced the proportion of patients who relapsed at 2 years, the primary endpoint, by 49% vs. placebo (p<0.0001). On secondary endpoints, BG-12 significantly reduced ARR and disability progression as measured by the EDSS by 53% and 38%, respectively, vs. placebo at 2 years. BG-12 also significantly reduced the number of new or newly-enlarging T2 hyperintense lesions by 85% and the number of new gadolinium-enhancing lesions by 90% vs. placebo. Biogen Idec said that data for the thrice-daily dose of BG-12 were similar to that of the twice-daily dose. Earlier this month, the company reported top-line data showing that both doses of BG-12 met the primary and all secondary endpoints vs. placebo (see BioCentury, April 18). ...