Pfizer Inc. (NYSE: PFE) today announced positive topline results from a Phase 3 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 2 studies.
These positive results demonstrate that etrasimod, if approved, could be a potential breakthrough option for patients with ulcerative colitis who aren’t able to experience improvement on current therapies,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “This outcome represents a continuation of our effort to develop new therapeutic approaches to treat immuno-inflammatory diseases and address the need for oral therapies for UC patients with inadequate response, loss of response, or intolerance to conventional or advanced therapies.”
The global phase 3 multi-center, randomized, 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.
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. Additional information about the studies can be found at www.clinicaltrials.gov under the identifiers NCT03996369 and NCT03945188.
Etrasimod was developed by Arena Pharmaceuticals, which was recently acquired by Pfizer.