Everest Medicines said that etrasimod has shown improvements in the primary endpoint in a multi-centre Phase 3 clinical trial in moderate-to-severe active ulcerative colitis (UC).
Etrasimod is an oral sphingosine 1-phosphate (S1P) receptor modulator that is to be taken once a day. It is designed to selectively bind with S1P receptor subtypes 1, 4, and 5.
The drug was approved in October this year by the US Food and Drug Administration (FDA) to treat moderate to severe active UC in adults under the VELSIPITY brand name.
In the late-stage study, etrasimod treatment produced a clinically meaningful and statistically significant improvement in the primary endpoint as well as in all key secondary and other secondary endpoints after the 12-week induction treatment period.
Etrasimod 2mg therapy was generally well tolerated with no new safety findings. The drug’s safety profile matched with that of previous studies.
Following induction therapy, patients who showed improvement were re-randomised to either a placebo or 2mg of the S1P receptor modulator once daily for 40 weeks of maintenance treatment.
Everest Medicines CEO Rogers Yongqing Luo 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.”
The randomised, double-blind, and placebo-controlled late-stage study assessed Etrasimod 2mg in Asian countries, including mainland China, Taiwan, and South Korea.
It randomised patients with inadequate response or intolerance to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy to get etrasimod 2mg once-daily or placebo for 12 weeks of induction treatment.
Etrasimod was developed by Arena Pharmaceuticals, which was purchased by Pfizer in 2022.
In 2017, Everest Medicines acquired exclusive rights from Arena Pharmaceuticals to create, produce, and market the S1P receptor modulator in Greater China and South Korea.
