Everest Medicines has completed patient enrollment in a Phase III trial investigating etrasimod in Asia for the treatment of moderate-severe active ulcerative colitis (UC).
In December 2022, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) accepted regulatory submissions for etrasimod in UC. A decision is expected in the second half of 2023 for FDA and 2024 for EMA. If successful, it would be the first approval of etrasimod globally.
Two Phase III trials (ELEVATE UC 52 and ELEVATE UC 12) have been conducted to evaluate the safety and efficacy of etrasimod 2 mg once daily on clinical remission in UC patients who did not respond to previous therapy. Both trials were successful showing higher clinical remission rates in the etrasimod group compared to placebo. The proportion of patients experiencing serious adverse effects was similar between treatment groups in both trials. Data from these trials were used as part of Pfizer’s NDA submissions.
Etrasimod is an oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator. The candidate was developed by Arena Pharmaceuticals, which was acquired by Pfizer in 2022. In 2017, Everest obtained exclusive rights to develop, manufacture and commercialise etrasimod in Greater China and South Korea.
“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,” said Rogers Yongqing Luo, Everest Medicines CEO.