Ponesimod, an investigational selective S1P1 receptor modulator, was more effective at treating adults with relapsing multiple sclerosis than Aubagio, according a study presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
“This is the first large controlled head-to-head study comparing two oral compounds for the treatment of relapsing MS,” Ludwig Kappos, MD, chair of the department of neurology at University Hospital in Basel, Switzerland, stated in a press release. “Notably, we saw superiority of the investigational agent ponesimod when compared to [Aubagio (teriflunomide, Sanofi Genzyme)] across the primary and most secondary endpoints.”
In OPTIMUM, a 2-year, head-to-head, phase 3 study, researchers compared the efficacy, safety and tolerability of ponesimod 20 mg and teriflunomide 14 mg among those with relapsing MS.
The study included 1,133 participants at 162 study sites in Canada, Europe, Mexico and the United States. Those enrolled in the study underwent 108 weeks of treatment.
At week 108, those who received ponesimod experienced a 30.5% greater reduction in annualized relapse rate compared with those who took teriflunomide (annualized relapse rate = 0.202 for ponesimod 20 mg vs. 0.29 for teriflunomide 14 mg; P = .0003)
The reduction in combined unique active lesions from baseline to week 108 was 56% lower (P <.0001) in the ponesimod group compared with the teriflunomide group.
Fatigue symptoms from baseline to the end of the treatment period were more improved with ponesimod than teriflunomide.
“These data, in conjunction with the observed safety profile, underline the potential of ponesimod as a new treatment option for MS,” Kappos said.
Data from the study will be used in regulatory submissions to the FDA and the European Medicines Agency for approval of ponesimod as a treatment for relapsing MS, according to the press release. – by Erin Michael
Kappos L, et al. Abstract 93. Presented at: European Committee for Treatment and Research in Multiple Sclerosis. Sept. 11-13, 2019; Stockholm.
Disclosure: Kappos is a consultant to Actelion Pharmaceuticals Ltd., a Janssen pharmaceutical company of Johnson & Johnson.