Laquinimod, made by Teva who partnered with Active Biotech, met the endpoint in the late-stage 1106-patient ALLEGRO trial, demonstrating a 23% reduction in annual relapse rates (AAR) compared to placebo. The study also showed that patients had a 36% reduction in any progression of disability and a 33% decrease in brain atrophy, compared to placebo. Elevated liver enzymes, relative to placebo, were present in some patients, but these increases did not lead to liver problems.
Teva and Active Biotech plan to file for regulatory approval of laquinimod once results from the phase III BRAVO trial are released.
Biogen presented positive results from DEFINE, the first of two phase III trials evaluating BG-12 (dimethyl fumarate) as an oral monotherapy in people with relapsing-remitting MS. Results showed that 240 mg of BG-12, administered either twice or three times a day, met the primary study endpoint, demonstrating a reduction in patients who relapsed at two years compared with placebo. Additional analyses of DEFINE are ongoing.