Positive top-line results from yearlong phase III trial of etrasimod in ulcerative colitis, underscoring best-in-class potential. - Pfizer
Pfizer Inc. announced positive top-line results from a second Phase III study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC).
The positive 12- and 52-week results from ELEVATE UC 52 follow the recent announcement of positive 12-week findings from the ELEVATE UC 12 trial on March 23. In this 52-week study, also known as ELEVATE UC 52, etrasimod patients achieved statistically significant improvements in the co-primary endpoints of clinical remission at weeks 12 and 52 when compared to placebo. Statistically significant improvements were attained in all key secondary endpoints at both 12 and 52 weeks. Etrasimod demonstrated a safety profile consistent with previous studies, including the Phase II OASIS trial.
The global Phase III multi-center, randomized, double-blind, placebo-controlled study enrolled 433 UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Participants received etrasimod 2 mg or placebo once-daily. ELEVATE UC 52 utilized a treat-through design in which patients were eligible to continue with their randomized treatment independent of whether they reached the objective criteria of clinical response at week 12.
Full results from the studies will be submitted for future scientific publication and presentation. These data, along with results from ELEVATE UC 12 and the long-term extension from these two trials (ELEVATE UC OLE), are expected to form the basis for planned future regulatory filings. Pfizer expects to initiate regulatory filings later this year.
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