Janssen announced positive top-line results from the phase 3 OPTIMUM study of ponesimod in adult patients with relapsing multiple sclerosis.
Ponesimod is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that reduces the number of circulating lymphocytes by inhibiting S1P activity. The investigational drug is believed to prevent immune cells from crossing the blood-brain barrier which leads to demyelination typically seen in patients with multiple sclerosis.
OPTIMUM was a prospective, multicenter, randomized, double blind, active controlled, parallel group, phase 3 superiority study that compared the efficacy and safety of oral ponesimod 20mg to teriflunomide 14mg (Aubagio; Sanofi Genzyme) in adult patients (N=1133) with relapsing multiple sclerosis for a duration of 108 weeks. The primary end point was the annualized relapse rate (ARR) up to the end of the study; a key secondary end point included the change from baseline to week 108 in fatigue-related symptoms.
Results showed the study met the primary end point and most of the secondary end points. Full detailed data will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2019.
The Company plans to use data from the OPTIMUM study to seek approval of ponesimod from the Food and Drug Administration (FDA) later this year.
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