Actelion's ponesimod meets RRMS endpoint
Actelion Ltd. (SIX:ATLN) said once-daily oral ponesimod met the primary endpoint in a Phase IIb trial to treat relapsing-remitting multiple sclerosis. The product significantly reduced the cumulative number of new active inflammatory lesions as measured by T1-weighted MRI brain scans at weeks 12, 16, 20 and 24 after initiation of treatment vs. placebo (p<0.0001). Actelion also said that ponesimod showed a "clinically meaningful effect" compared to placebo on the secondary endpoint of annualized relapse rate (ARR), but did not provide details. The double-blind trial enrolled 464 patients.
Actelion said it plans to discuss details of its Phase III program for ponesimod with regulatory authorities worldwide after full analysis of the Phase IIb data has been completed. Ponesimod is a sphingosine 1-phosphate receptor 1 ( S1PR1; S1P1; EDG1) agonist. ...