Janssen Pharmaceutical has reported top-line data from the Phase III OPTIMUM clinical trial of ponesimod in relapsing multiple sclerosis patients, revealing that the study met its primary endpoint.
Ponesimod is a selective inhibitor of sphingosine-1-phosphate receptor 1 (S1P1).
It is believed to work by decreasing the number of circulating lymphocytes, blocking immune cells from crossing the blood-brain barrier and affecting myelin, which is already damaged in multiple sclerosis.
OPTIMUM compared the safety, efficacy, and tolerability of 20mg ponesimod with a 14mg dose of Sanofi’s Aubagio (teriflunomide) over 108 weeks.
The head-to-head, prospective, multi-centre, randomised, double-blind, active-controlled, parallel-group trial enrolled a total of 1,133 adult patients.
The primary endpoint was annualised relapse rate (ARR) up to the end of the superiority trial, while the change in fatigue-related symptoms from baseline to week 108 was measured as a key secondary endpoint.
Additional secondary endpoints included the total number of combined unique active lesions (CUALs), time to first 12-week confirmed disability accumulation (CDA), and time to first 24-week CDA from baseline to study completion.
Janssen said that the OPTIMUM trial met the majority of the secondary endpoints.
Ponesimod’s safety profile was observed to be consistent with its previous studies and known profile for other S1P receptor modulators.
Trial data will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2019.
These findings are also intended to support applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for ponesimod in relapsing forms of multiple sclerosis.
The company plans to file regulatory submissions by the end of this year.