Johnson & Johnson unit Janssen Pharmaceutical has reported positive data from the Phase III OPTIMUM trial, where its ponesimod demonstrated superior efficacy compared to Sanofi’s Aubagio (teriflunomide) in relapsing multiple sclerosis (MS) patients.
Ponesimod is an investigational, selective modulator of sphingosine-1-phosphate receptor 1 (S1P1). It is designed to block S1P activity and decrease the number of circulating lymphocytes.
The drug is believed to work by preventing immune cells from crossing the blood-brain barrier and damaging myelin in relapsing-remitting MS patients.
OPTIMUM is a head-to-head trial that compared the safety, efficacy and tolerability of 20mg ponesimod with 14mg teriflunomide in 1,133 adult patients over 108 weeks at 162 sites across multiple countries.
The primary endpoint was annualised relapse rate (ARR), measured as the number of confirmed relapses per subject-year, from baseline to week 108. Ponesimod met the endpoint with statistically significant ARR reduction compared to teriflunomide.
Janssen added that its drug showed superior efficacy on the majority of the trial’s secondary endpoints.
Compared to teriflunomide, patients treated with ponesimod experienced statistically significant effects on fatigue symptoms determined using the Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS) at week 108.
The safety profile of ponesimod was also found to be consistent with previous trials and also the known profile of other S1P receptor modulators.
Janssen Research & Development global head Luc Truyen said: “Despite an ever-growing treatment landscape, unmet needs remain in helping patients with MS.
“We are thrilled to be here at ECTRIMS to present these pivotal findings as they mark the first head-to-head trial of two oral therapies for relapsing MS and demonstrate positive results for ponesimod compared to a leading disease-modifying therapy.”
Based on the OPTIMUM study results, the company plans to file regulatory applications in the US and Europe for the approval of its drug as a relapsing MS treatment.