Experimental Medications: Other Therapeutic Strategies
Ponesimod is another selective S1P receptor modulator that completed a Phase II trial; results were reported in 2012.59 In this study, 462 people with RRMS were randomized to placebo or 10 mg, 20 mg, or 40 mg of ponesimod. Reductions in annualized relapse rate and new lesions were seen for all treatment groups as compared with placebo.
However, the 40-mg dose generated an increase in adverse events, which included swelling of the extremities and difficulty breathing. With an 83-percent decrease in gadolinium enhancing lesions and a favorable adverse event profile, the 20-mg dose of ponesimod may have the best benefit-to-risk profile in this trial. An extension trial60 over two years presented in 2013 demonstrated continued efficacy and no new safety issues emerged. A decision regarding the continued development of ponesimod in a Phase III trial in RRMS is expected in early 2015.