Novartis AG (NYSE:NVS) has announced that the Phase III EXPAND study, which is evaluating the efficacy and safety of oral, once daily, BAF312 in secondary progressive multiple sclerosis (SPMS), has met its primary endpoint of reducing the risks of disability progression, compared with placebo.
The EXPAND study represented the largest randomized, controlled study in SPMS to date. It compared the safety and efficacy of BAF312 to placebo in people with secondary progressive multiple sclerosis. The study included 1,651 participants with SPMS from 31 countries. These patients were randomized to receive either placebo in a 2:1 ratio or 2mg BAF312 respectively.
A delay of 3 months in time to confirmed disability progression versus placebo was the primary endpoint of the study. The secondary endpoint included a delay in the time to six months confirmed disability progression in comparison with placebo, the time to confirmed worsening of at least 20% from baseline in the timed 25-foot walk test, T2 lesion volume, and the tolerability and safety of BAF312 in people with SPMS.
The top line results of the EXPAND study including both the primary and secondary endpoints will be presented as a late-breaking oral abstract at the 32nd meeting of the European Committee for Treatment and Research in Multiple Sclerosis. Novartis is expected to carefully complete the analyses of the data and also evaluate the next steps in consultation with health officials.
Vasant Narasimhan, the Global Head of Drug Development and Chief Medical Officer for Novartis noted that SPMS is a particularly disabling form of MS, and there is a need for an efficient treatment option to assist in the delaying if disability progression in those living with the condition. He further noted that the positive EXPAND data are encouraging for a disease with a high unmet need and looks forward to sharing the results at the upcoming ECTRIM congress.
