Phase II Data Support Ongoing Study of Amiselimod in Relapsing Multiple Sclerosis

Fingolimod is an FDA-approved sphingosine 1-phosphate (S1P) modulator that acts on subreceptors S1P_1,3,4,5. By contrast, the investigational drug amiselimod has greater specificity for S1P₁, which is thought to have a decreased effect on the cardiac conduction system. In this randomized, double-blind, placebo-controlled, 24-week, manufacturer-funded, multicenter dose-finding study, investigators randomized 415 participants to four arms: placebo or amiselimod in 0.1-mg, 0.2-mg, or 0.4-mg daily doses.

New gadolinium-enhancing (GdE) lesions were reduced by 61% in the 0.2-mg group and 77% in the 0.4-mg group, compared with placebo. At 24 weeks, 85% of patients in the 0.2-mg group and 91% of the 0.4-mg group were free of GdE lesions. Annualized r…