Positive Results Released for Novartis’ BAF312 in Secondary Progressive MS Patients

Pharmaceutical giant Novartis released promising news ahead of the official release of their results from the largest controlled study surrounding individuals with secondary progressive multiple sclerosis (SPMS).1  SPMS generally supersedes relapse-remitting multiple sclerosis (RRMS) in the progression of MS.  At this stage, individuals experience a degradation of neurological function, and previously, there have been few treatment options for this population.

Although the results of the 1,651 patient Phase III EXPAND trial are set to be discussed in detail in London next month at the European Committee for Treatment and Research in Multiple Sclerosis (ETRIMS), Novartis has just revealed that the randomly controlled trial succeeded in meeting its primary endpoint. This goal was for individuals taking 2mg of once-daily BAF312 (siponimod) to display a reduced risk of three-month confirmed disability progression when compared to their counterparts given a placebo.  The study had a 2:1 ratio of treatment versus placebo, and the disability progression was measured using the expanded disability status scale (EDSS).

The new BAF312 medication is a modulator for certain S1P receptor cells in the central nervous system.  These receptor cells play a role in the loss of neurological function in individuals with SPMS.  Controlling these receptor cells could be the key to halting the loss of function in SPMS.  With few treatment options for individuals with SPMS, the need for something that shows promise is key.

"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.  The positive EXPAND data are encouraging for a disease with such a high unmet need."

-Vasant Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis

Whether or not any of the secondary endpoints of the 31-country-spanning study were fulfilled—which include a decrease in the time to 6-month confirmed disability progression versus placebo, T2 lesion volume, annualized relapse rate, time to confirmed worsening of at least 20% from baseline in the timed 25-foot walk test, and the overall tolerability and safety of the new treatment—has not yet been disclosed.  These results are among those expected to be discussed in London next month as well.

Novartis currently has medications on the market for RRMS, including Gilenya (fingolimod) and Extavia (interferon beta-1b for subcutaneous injection), as well as the current development and testing of a monoclonal antibody in-licensed from GlaxoSmithKline called ofatumumab (OMB157).  However, BAF312 will be the first geared towards individuals with SPMS.  According to these preliminary results, the drug seems to be a promising and much needed treatment geared towards individuals with SPMS, that Novartis is aiming to get to regulators to implement for treatment in 2019.

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