Pfizer Announces Positive Topline Results from One-Year Phase 3 Trial of Etrasimod in Ulcerative Colitis, Highlighting Best-in-Class Potential

SHANGHAI, March 30, 2022 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE), the authorized partner of Everest Medicines (HKEX 1952.HK), announced positive topline results from the second Phase 3 clinical trial of etrasimod. Etrasimod is an investigational once-daily oral selective sphingosine-1-phosphate (S1P) receptor modulator being developed for the treatment of moderate to severe active ulcerative colitis (UC).

In this 52-week study (also known as ELEVATE UC 52), patients receiving etrasimod achieved statistically significant improvements in the co-primary endpoints of clinical remission at weeks 12 and 52 compared to placebo. All key secondary endpoints showed statistically significant improvements at weeks 12 and 52. The safety profile of the drug was consistent with previous studies, including the Phase 2 OASIS trial.

This global Phase 3 multicenter, randomized, double-blind, placebo-controlled study enrolled 433 patients with ulcerative colitis who had previously failed or were intolerant to at least one conventional therapy, biologic, or Janus kinase (JAK) inhibitor. Patients in the study received either 2 mg of etrasimod or placebo once daily. ELEVATE UC 52 employed a continuous treatment design, in which patients were eligible to continue receiving randomized treatment regardless of whether they met the objective criteria for clinical response at week 12.

The full results of the study will be used for publication in scientific journals and reports. Pfizer also announced the positive results of the ELEVATE UC 12 trial at week 12 earlier this month. The latest released data, ELEVATE UC 12 data, and the results from the long-term extension studies of these two trials are expected to be used for regulatory submissions.Pfizer is expected to begin regulatory submissions later this year.

Etrasimod was developed by Arena Pharmaceuticals, which Pfizer recently acquired. In 2017, Everest Medicines obtained exclusive rights to develop, manufacture, and commercialize etrasimod in Greater China and South Korea from Arena Pharmaceuticals. Everest Medicines is currently conducting a Phase 3 clinical trial of etrasimod for the treatment of moderate to severe ulcerative colitis in Asia, with patient enrollment expected to be completed in 2023.

Dr. Corey Brauer, CEO of Everest Medicines, stated: "We are delighted to see etrasimod achieve positive top-line results once again, indicating its potential to become...Best-in-class Therapy"We will actively promote the Phase 3 study being conducted in Asia to bring this product to patients with moderate to severe ulcerative colitis in the region as soon as possible."