Biogen has reported positive top-line results from the first of two Phase III clinical trials to evaluate the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy for relapsing-remitting multiple sclerosis.
The results showed that 240mg of BG-12, administered twice or three times a day, met the primary study endpoint, demonstrating a statistically significant reduction in the proportion of relapsing-remitting multiple sclerosis patients who relapsed at two years compared to the placebo.
Both doses of BG-12 also met all of the secondary study endpoints, providing a statistically significant reduction in annualised relapse rate, number of new or newly enlarging T2 hyperintense lesions, new gadolinium-enhancing lesions and the rate of disability progression as measured by the Expanded Disability Severity Scale at two years.
BG-12 also demonstrated a favourable safety and tolerability profile in the study.
The global, randomised, double-blind and placebo-controlled dose-comparison study was to determine the efficacy and safety of BG-12 in more than 1,200 people with the condition.
BG-12 received fast-track designation from the US Food and Drug Administration in 2008.