Pfizer announces positive results for phase-III trial of Etrasimod in Ulcerative Colitis patients

Pfizer yesterday announced positive results from a 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). In the study, Etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo. Statistically, significant improvements were achieved in all key secondary endpoints in the trial as well. The safety profile was consistent with previous phase-II studies, a company statement said.

The global phase-III multi-centre, randomised, double-blind, placebo-controlled study, also known as Elevate 12, enrolled 354 UC patients who had previously failed or were intolerant to at least one conventional, biologic or JAK therapy. Participants received Etrasimod 2mg once daily, it added.

The statement notified that full results from the study will be submitted for future scientific publication and presentation. These data, along with results from Elevate 52 are expected to form the basis for planned future regulatory filings. Results from the Elevate 52 study will be available by the end of Q1.

Etrasimod was developed by Arena Pharmaceuticals, which was recently acquired by Pfizer, concluded the statement.