BG-12: Phase III data

Top-line data from the double-blind, international Phase III DEFINE trial in >1,200 patients showed that twice- and thrice-daily 240 mg oral BG-12 met the primary endpoint of significantly reducing the proportion of patients who relapsed at 2 years vs. placebo (p<0.0001). Both doses of BG-12 also met all secondary endpoints vs. placebo at 2 years, including significantly reducing ARR, the number of new or newly-enlarging T2 hyperintense lesions, the number of new gadolinium-enhancing lesions, and the rate of disability progression as measured by the EDSS. The overall incidence of adverse and serious adverse events was similar between treatment groups. ...