Novartis has reported positive Phase III EXPAND trial results of BAF312 (siponimod) to treat secondary progressive multiple sclerosis (SPMS).

BAF312 has been developed as a selective modulator of specific types of the sphingosine-1-phosphate (S1P) receptor.

Found on the surface of specific cells residing in the central nervous system (CNS), the S1P receptor is considered responsible for causing CNS damage resulting to loss of function in secondary progressive MS (SPMS).

BAF312 is believed to inhibit the activation of these harmful cells by binding to these specific receptors thereby helping to reduce loss of physical and cognitive function associated with SPMS.

The randomised, double-blinded, placebo-controlled Phase III EXPAND trial compared the safety and efficacy of BAF312 against placebo to treat SPMS.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The trial involved 1,651 people who were randomised in a 2:1 ratio to be administered with either BAF312 or placebo.

It was primarily focused to reduce the risk of the disease progression when compared against placebo determined on the basis of expanded disability status scale (EDSS).

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

The secondary goals of the trial were to determine the delay in the time to six-month confirmed disability progression against placebo, T2 lesion volume, annualised relapse rate (ARR), and the safety and tolerability of BAF312 when administered to people with SPMS.

Study results suggested that it achieved its primary endpoint.

Novartis drug development global head 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."

Image: Multiple sclerosis detected in MRI scan. Photo: courtesy of James Heilman.