Positive Phase III EXPAND study for NovartisAugust 25, 2016
Novartis has announced the Phase III EXPAND study, evaluating the efficacy and safety of oral, once-daily, BAF312 (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.
In a press release on Thursday, the company’s Global Head of Drug Development and Chief Medical Officer for Novartis, Vasant Narasimhan, said that SPMS was a particularly disabling form of MS, and there was a need for effective treatment options to help delay disability progression in those living with the condition
“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,” Narasimhan has said.
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. Novartis will complete full analyses of the data and evaluate next steps in consultation with health authorities.