Positive Top-Line Results Announced for Multiple Sclerosis Drug

Novartis experimental drug BAF312 met its primary endpoints in a phase 3 study.

Novartis recently announced positive results from a phase 3 study analyzing the efficacy and safety of BAF312 (siponimod) for the treatment of secondary progressive multiple sclerosis (SPMS).

Currently, there are limited treatments for patients with SPMS, a form of multiple sclerosis associated with gradual worsening of symptoms and accumulation of disability, independent of relapses, according to a press release from Novartis. BAF312 met its primary endpoint by reducing the risk of 3-month confirmed disability progression, which was measured by the expanded disability status scale.

The EXPAND study included 1651 patients with secondary progressive multiple sclerosis randomized to either receive treatment with BAF312, or a placebo. To date, it is the largest randomized, controlled study investigating SPMS treatments.

Secondary endpoints were delay in the time to 6-month confirmed disability progression, time to confirmed worsening of at least 200% from baseline in the timed 25-foot walk test, T2 lesion volume, annualized relapse rate, safety, and tolerability, according to Novartis. Results from the EXPAND study will be presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

“SPMS is a particularly disabling form of MS, and there is a need for effective treatment options to help delay disability progression in those living with the condition,” said Vasant Narasimhan, global head of Drug Development and chief medical officer for Novartis. “The positive EXPAND data are encouraging for a disease with such a high unmet need. We look forward to sharing the results at the upcoming ECTRIMS congress, and thank all of the study participants and investigators.”