Siponimod May Delay Disability Progression in Secondary Progressive Multiple Sclerosis

Novartis recently announced positive results from the phase 3 EXPAND clinical trial of siponimod in secondary progressive multiple sclerosis (SPMS). Siponimod is an investigational selective modulator of sphingosine-1-phosphate receptor subtypes 1 and 5.

The study met its primary endpoint of substantial reductions in 3- and 6-month confirmed disability progression with siponimod compared with placebo, according to a press release. The results also suggest that treatment with siponimod is associated with other benefits related to MS disease activity.

If approved, siponimod would be the first disease-modifying treatment to delay SPMS disability progress, according to Novartis.

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Many patients with SPMS reach a non-relapsing disease stage and a significant level of disability. Patients typically develop SPMS after an initial diagnosis of relapsing-remitting MS.

There is currently an unmet clinical need for safe and effective treatments for patients with SPMS, making the promise of siponimod significant, according to the release.

"Today's published, full EXPAND results show that siponimod can delay disability progression in typical established SPMS patients, where other approaches tested so far have been unsuccessful," principal investigator Ludwig Kappos, MD, said last week. "These data are all the more impressive when considering that the majority of patients already had advanced disability when starting treatment in EXPAND."

Data from the EXPAND clinical trial showed that treatment with siponimod reduced the 3-month confirmed disability rate by 21% versus placebo, according to the release. The researchers reported that efficacy was consistent among patient subgroups.

Treatment with siponimod was also found to reduce the 6-month confirmed disability rate by 26%, according to the release.

Notably, brain volume loss was lowered by 23% among patients treated with siponimod, in addition to limiting T2 lesion volume by 80%.

Siponimod therapy was also found to reduce annualized relapse rate by 55% compared with placebo, according to the release.

Due to these positive findings, Novartis plans to file for regulatory approval of siponimod in SPMS this year with the FDA and the European Medicines Agency.

"Novartis is dedicated to advancing MS research and pioneering solutions for people living with SPMS—a complex, debilitating disease," said Danny Bar-Zohar, global head, Neuroscience Development, Novartis. "The pivotal EXPAND data provides patients, and the medical community alike, with hope that a much needed, safe and effective treatment option is on the horizon for SPMS, for which treatment options are scarce. We look forward to continuing to work with regulatory agencies to make siponimod available for these patients as fast as possible."