Define trial results showed two-year treatment with BG-12 significantly reduced relapse rate and development of new lesions.
Biogen Idec reported positive data from a Phase III study evaluating oral BG-12 (dimethyl fumarate) therapy in patients with relapsing-remitting multiple sclerosis (RRMS). Two-year data from the Define study showed that compared with placebo therapy, treatment using oral BG-12 either twice a day (BID) or three times a day (TID) significantly reduced the proportion of patients who relapsed by 49% and 50%, respectively.
The 1,237-patient study in addition showed that BG-12 BID and TID reduced the annualized relapse rate (ARR) by 53% and 48%, respectively, and the risk of disability progression by 38% and 34%, respectively. MRI evaluation showed that at two years, treatment with BG-12 BID and TID had, respectively, reduced the mean number of new or newly enlarging T2 hyperintense lesions by 85% and 74%, reduced the mean number of Gd+ lesions by 90% and 73%, and led to 72% and 63% lower numbers of new T1 hypointense lesions.
Topline data from a second Phase III study, Confirm, are expected by the end of 2011. “Results from our second Phase III trial, Confirm, will provide additional insight into BG-12’s profile, as well as a comprehensive dataset to further discussions with regulatory authorities,” comments Doug Williams, Ph.D., Biogen Idec executive vp for R&D. “The significant clinical and radiological responses in Define are further evidence that BG-12 may become an oral therapy of choice for MS patients.”