The 1100-patient study is comparing once-daily ponesimod and teriflunomide for patients with the relapsing form of the disease.
A phase 3 multi-center, randomized, double-blind, parallel group, active-controlled superiority study assessing oral ponesimod versus teriflunomide (Aubagio) in relapsing multiple sclerosis (MS) (OPTIMUM) is nearing its estimated primary completion date of April 17, 2019.
The 1100-patient study, which kicked off in June 2015, is a comparison of the efficacy and safety of once-daily 20 mg ponesimod and 14 mg teriflunomide. The primary outcome measure is annualized relapse rate (ARR) with secondary outcome measures of time to 12-week confirmed disability accumulation (CDA), percent change in brain volume (PCBV), time to first confirmed relapse, cumulative number of combined unique active lesions (CUAL), and change from baseline to week 108 in fatigue-related symptoms.
Ponesimod is an orally active, selective sphingosine-1-phosphate receptor 1 (S1P1) immunomodulator which prevents lymphocytes from leaving lymph nodes, thus rapidly reducing circulating blood lymphocyte counts and preventing infiltration of lymphocytes into target tissues. In a double-blind, placebo-controlled, dose-finding phase 2b study evaluating ponesimod, study author Tomas Olsson, MD, PhD, and colleagues found that ponesimod 10, 20, or 40 mg was well-tolerated and significantly reduced the number of new T1 Gd+ lesions at weeks 12-24 of the 24-week trial.
Analysis of pharmacokinetics revealed that ponesimod has a favorable safety profile that allows for maximizing its ability to inhibit circulating lymphocytes in a given dosing regimen. It can be sustained with continued dosing, and with its short half-life, is rapidly eliminated upon discontinuation.
“Our clinical development program for ponesimod in multiple sclerosis was already innovative when we decided to move into phase 3,” Guy Braunstein, MD and Head of Global Clinical Development at Actelion Ltd., said in a statement. “OPTIMUM is the first study in MS to target superiority over a commercialized oral therapy. It also includes a number of patient-oriented outcome assessments.”
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