Novartis ($NVS) has hit the primary endpoint in what it says is the largest randomized, controlled study to date to treat secondary progressive multiple sclerosis (SPMS) patients. This is a form of multiple sclerosis that typically follows after relapsing-remitting multiple sclerosis (RRMS).
Most patients with RRMS eventually transition into SPMS in which there is progressive degradation of neurologic function; there are few treatment options for these patients.
"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, in a statement. "The positive EXPAND data are encouraging for a disease with such a high unmet need."
The pharma said that the oral, once-daily BAF312 (siponimod) met the primary endpoint of a reduction in disability progression risk as compared to placebo in the 1,651-patient EXPAND trial. Patients were randomized to drug and placebo at a 2:1 ratio, respectively.
It didn’t disclose if the trial met the secondary endpoints of delay in the time to 6-month confirmed disability progression versus placebo, the time to confirmed worsening of at least 20% from baseline in the timed 25-foot walk test, T2 lesion volume, annualized relapse rate, and the safety and tolerability of BAF312 in people with SPMS.
The primary endpoint was measured at three months using the expanded disability status scale (EDSS). Detailed data on the primary and secondary endpoints will be presented as a late-breaker at European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in London in September.
Novartis has a substantial commitment to multiple sclerosis; it markets S1P modulator Gilenya (fingolimod) and Extavia (interferon beta-1b for subcutaneous injection) both in relapsing MS. Extavia is also approved in Europe to treat secondary progressive MS (SPMS) in active disease patients. Novartis is also developing monoclonal antibody ofatumumab (OMB157), which it in-licensed last year from GlaxoSmithKline ($GSK), to treat relapsing MS with Phase III trials slated to start in the second half.
Via its generic Sandoz division, Novartis also markets MS treatments Glatopa (glatiramer acetate injection), the first generic version of Teva's Copaxone.
Novartis had pushed back the release of this data a bit from the anticipated mid-year timeline.
“In terms of BAF312, we originally had planned to lock the database in Q2. We will lock the database in Q3,” said Vasant Narasimhan, Novartis Global Head Drug Development and CMO, on the company’s most recent earnings call.
He added, “This is primarily because of our wanting to assure that we had solid data, given the length of the study. And we had just some quality issues we wanted to resolve.”
The pharma plans to submit BAF312 to regulators to treat SPMS in 2019.
- here is the release
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