Pfizer's Ulcerative Colitis Candidate Aces Late-Stage Study
- Pfizer Inc (NYSE: PFE) has announced topline results from a Phase 3 study of etrasimod in 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 compared with placebo.
- Statistically significant improvements were achieved in all key secondary endpoints in the trial.
- The safety profile was consistent with the previous Phase 2 studies.
- Etrasimod is an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator.
- The global phase 3 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.
- Full results from the study will be submitted for future scientific publication and presentation.
- These data, along with results from ELEVATE 52 study, are expected to form the basis for planned future regulatory filings.
- The ELEVATE 52 study results will be available by the end of Q1.
- Etrasimod was developed by Arena Pharmaceuticals, which Pfizer recently acquired.
- Price Action: PFE shares are down 0.93% at $52.55 on the last check Wednesday.
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Posted-In: Briefs Phase 3 Trial ulcerative colitisBiotech News Health Care General
