Policy & Regulation
Everest Medicines announces positive topline data from multi-centre Phase three Etrasimod clinical trial in Asia
1 December 2023 -

Everest Medicines (HKEX 1952.HK), a China-based biopharmaceutical company, announced on Thursday positive topline data from a multi-centre Phase three clinical trial of Etrasimod in Asia intended for the treatment of moderate-to-severe active ulcerative colitis (UC).

The product was approved in October this year for the treatment of moderately to severely active UC in adults by the US Food and Drug Administration (FDA) as VELSIPITY.

The multi-centre, randomised, double-blind and placebo-controlled Phase 3 trial of etrasimod 2mg was conducted in Asian countries, including mainland China, China Taiwan and South Korea. Patients with inadequate response or intolerance to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy were randomised to receive etrasimod 2mg once-daily or placebo for 12 weeks of induction treatment. The company said that Etrasimod treatment resulted in a clinically meaningful and statistically significant improvement in the primary endpoint and all key secondary and other secondary endpoints (including mucosal healing, symptomatic remission and endoscopic normalisation) after the 12-week induction treatment period. In general, treatment with etrasimod 2mg was well tolerated.

Rogers Yongqing Luo, Everest Medicines' chief executive officer, said, 'We are pleased to report that the induction period of Phase 3 trial of etrasimod conducted in Asia for the treatment of moderate-to-severe active ulcerative colitis yielded both clinically meaningful and statistically significant results. Etrasimod is expected to provide a once-daily oral treatment option with a favourable benefit-risk profile for moderate-to-severe ulcerative colitis. Autoimmune disease is a key therapeutic focus for Everest Medicines, and we plan to quickly advance the late-stage study of etrasimod towards registration filings in China and other Asian markets.'