Siponimod Reduces Risk of Disability Progression in Secondary Progressive MS

Novartis plans to file siponimod for US approval in SPMS in early 2018
Novartis plans to file siponimod for US approval in SPMS in early 2018

Results from the Phase 3 EXPAND trial demonstrate that siponimod (BAF312; Novartis), a selective sphingosine 1-phosphate (S1P) receptor modulator, reduces the risk of 3-month and 6-month confirmed disability progression in patients with secondary progressive multiple sclerosis (SPMS).

In EXPAND, patients with SPMS (n=1651) were randomized to receive once daily siponimod 2mg or placebo. The primary endpoint of the study was time to 3-month confirmed disability progression (CDP).

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Results showed that compared to placebo, siponimod significantly reduced the risk of 3-month CDP by 21% (hazard ratio [HR] 0.79, 95% CI 0.65–0.95; P=0.013). Moreover, siponimod reduced the risk of 6-month CDP by 26% (HR 0.74, 95% CI 0.60–0.92; P=0.0058), slowed the rate of brain volume loss by 23% (relative difference; mean across 12 and 24 months, P=0.0002), limited the increase of T2 lesion volume by about 80% (mean over 12 and 24 months, P<0.0001), and reduced annualized relapse rate by 55% (P<0.0001), all compared to placebo.

With regard to adverse events, siponimod demonstrated a safety profile similar to that of other S1P modulators. Elevated liver transaminases, bradycardia at treatment initiation, macular edema, hypertension, varicella zoster virus reactivation, and convulsions were observed more often in siponimod-treated patients than in patients in the placebo group.

"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," said Professor Ludwig Kappos, University Hospital Basel and Principal Investigator of EXPAND.

Novartis plans to file with the Food and Drug Administration (FDA) for regulatory approval of siponimod in SPMS in early 2018. If approved, the drug would be the first disease-modifying treatment to delay disability progression in typical SPMS patients.

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