Novartis’ BAF312 meets main goal in secondary progressive multiple sclerosis trial

Novartis claims that the Expand study is the largest study ever undertaken in SPMS.

More than 1,600 people with SPMS from 31 countries participated in the study. They were randomized to receive either 2mg BAF312 or placebo in a 2:1 ratio respectively.

The study’s primary endpoint was an enhancement in the time to three-month confirmed disability progression, as measured by the expanded disability status scale, compared with placebo.

Secondary endpoints included delay in the time to six-month confirmed disability progression versus placebo, the time to confirmed worsening of about 20% from baseline in the timed 25-foot walk test, T2 lesion volume, annualized relapse rate, and BAF312’s safety and tolerability in people with SPMS.

BAF312 is a selective modulator of specific types of the sphingosine-1-phosphate (S1P) receptor, which is found on the surface of specific cells residing in the central nervous system (CNS).

The cells damage the CNS, resulting in loss of function in SPMS. BAF312 enters the brain and by binding to the specific receptors, may avoid the activation of the harmful cells, helping to lower loss of physical and cognitive function related with SPMS.

Novartis global head of drug development and chief medical officer Vasant Narasimhan said: "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. We look forward to sharing the results at the upcoming ECTRIMS congress, and thank all of the study participants and investigators."

The company said it will complete full analyses of the data and identify next steps by consulting with health authorities.

Image: Novartis headquarters in Basel. Photo: courtesy of –Andrew- from Flickr.