BAF 312 (siponimod) reports Phase III results in treatment of secondary progressive multiple sclerosis.-Novartis

Novartis announced the Phase III EXPAND study, evaluating the efficacy and safety of oral, once-daily, BAF 312 (siponimod) in secondary progressive multiple sclerosis (SPMS), met its primary endpoint of a reduction in the risk of disability progression, compared with placebo. The EXPAND study represents the largest randomized, controlled study in SPMS to date. Topline results of the EXPAND study, including primary and key secondary endpoints, will be presented as a late breaking oral abstract at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), September 17th, in London, UK.

The study included 1,651 people with SPMS from 31 countries. Patients were randomized to receive either 2mg BAF 312 or placebo in a 2:1 ratio respectively.The primary endpoint of the study was an improvement in the time to three-month confirmed disability progression, as measured by the expanded disability status scale (EDSS), versus placebo. Secondary endpoints included delay in the time to six-month confirmed disability progression versus placebo, the time to confirmed worsening of at least 20% from baseline in the timed 25-foot walk test (T25FW), T2 lesion volume, annualized relapse rate (ARR), and the safety and tolerability of BAF312 in people with SPMS.