"We are very pleased to achieve full patient enrollment in Asia ahead of schedule, which brings Everest an important step closer to offering etrasimod to patients in this region," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We look forward to advancing this late-stage study as quickly as possible towards registration in China and other Asian markets as the incidence of ulcerative colitis has been rapidly increasing in the region in recent years."

The number of UC patients in China is expected to more than double from 2019 to reach approximately one million by 2030, highlighting much-needed novel treatment for the disease. Etrasimod was developed by Arena Pharmaceuticals, which was acquired by Pfizer in 2022. Everest Medicines obtained exclusive rights from Arena to develop, manufacture and commercialize etrasimod in Greater China and South Korea in 2017.

In December 2022, our licensing partner Pfizer announced that the U.S. Food and Drug Administration (FDA) had accepted for review an NDA for etrasimod for individuals living with moderately-to-severely active UC, with a decision expected in the second half of 2023. A U.S. FDA approval would be the first approval of etrasimod globally. In addition, the European Medicines Agency accepted the Marketing Authorization Application for etrasimod in the same patient population, with the decision anticipated in the first half of 2024.

Pfizer's NDA submissions were based on previously announced results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of etrasimod 2 mg once daily on clinical remission in UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Both randomized, double-blind, placebo-controlled studies achieved all primary and key secondary endpoints, with a safety profile consistent with previous studies. In ELEVATE UC 52, clinical remission was 27.0% for patients receiving etrasimod compared to 7.4% for patients receiving placebo at week 12 (19.8% differential, P≤.001) and was 32.1% compared to 6.7% at week 52 (25.4% differential, P≤.001). In ELEVATE UC 12, clinical remission was achieved among 24.8% of patients receiving etrasimod compared to 15.2% of patients receiving placebo (9.7% differential, P=.0264) after 12 weeks.

In ELEVATE UC 12, a similar proportion of patients experienced treatment-emergent adverse events (AEs) between etrasimod 2 mg and placebo treatment groups, while in ELEVATE UC 52, it was higher in the etrasimod 2 mg group compared to placebo. The proportion of patients experiencing serious AEs was similar between treatment groups in both trials. The most common treatment-emergent AEs in 3% or more of etrasimod-treated patients and greater than placebo up to week 52 in either trial were headache, worsening of UC, COVID-19 infection, dizziness, pyrexia, arthralgia, abdominal pain and nausea. There were no reports of bradycardia or atrioventricular block as serious AEs. Data support initiation of etrasimod treatment does not require complex up-titration regimen.