Novartis heralds a PhIII success for secondary progressive MS drug
Novartis has scored a success for a Phase III study of BAF312 (siponimod), reducing the risk of crippling CNS damage in secondary progressive multiple sclerosis. The drug is in a class of S1P receptor modulators that has attracted considerable attention in the field.
Investigators set out to see if the drug could hit its primary endpoint: reducing the risk of three-month confirmed disability progression versus placebo. In secondary progressive MS patients continue to worsen independent of the periodic flare ups that afflict patients with relapsing-remitting MS.
Novartis recruited 1,625 patients for this study, billing it as the “largest randomized, controlled study in SPMS to date.”
BAF312 is part of Novartis’s MS pipeline, intended to replace Gilenya when it loses patent protection, possibly by 2019.
“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.”