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Biogen MS Drug Shows Promise

Biogen Idec achieved positive results from DEFINE, a Phase III trial to evaluate the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy in people with relapsing-remitting multiple sclerosis (RRMS).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Biogen Idec achieved positive results from DEFINE, a Phase III trial evaluating the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered either twice or three times a day, met the primary study endpoint, demonstrating a statistically significant reduction in patients with RRMS who relapsed at two years compared with placebo. Both doses of BG-12 also met all of the secondary study endpoints, providing a statistically significant reduction in annualized relapse rate, in the number of new or newly enlarging T2 hyperintense lesions, new gadolinium-enhancing (Gd+) lesions, and in the rate of disability progression at two years.

DEFINE, the first of two Phase III trials, was a global, randomized, double-blind, placebo-controlled, dose-comparison study to determine the efficacy and safety of BG-12 in people with RRMS. The trial also showed that BG-12 demonstrated a favorable safety and tolerability profile. BG-12 received Fast Track designation from the FDA in 2008.

“The significant clinical responses seen in the DEFINE study represent an important step forward in the development of BG-12 for multiple sclerosis (MS),” said Douglas Williams, Ph.D., Biogen Idec’s executive vice president of R&D. “We are very pleased with these data and believe that BG-12 has the potential to offer MS patients a highly effective oral treatment option with a strong safety profile.”
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