Everest's Etrasimod Shows Promising Results in P3 Trial for Ulcerative Colitis

Everest Medicines reports positive results from a Phase 3 trial in Asia for Etrasimod, a treatment for ulcerative colitis. The drug showed significant improvements in primary and secondary endpoints, with a favorable safety profile. Notably, etrasimod, marketed under the brand name Velsipity™, received approval from the FDA in Oct. 2023 for the treatment of moderately to severely active UC in adults.

In a significant stride, biopharmaceutical company Everest Medicines has announced positive topline results from the induction period of a Phase 3 clinical trial of Etrasimod in Asia for the treatment of moderate-to-severe active ulcerative colitis (UC). The trial demonstrated clinically meaningful and statistically significant results for the primary endpoint and key secondary endpoints over the 12-week induction period. This marks a crucial advancement for UC treatment, particularly in Asia, where the patient population is rapidly growing.

Rogers Yongqing Luo, CEO of Everest expressed excitement about the results, stating: "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 favorable 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."

Etrasimod: A New Hope for UC Patients

Etrasimod is an oral medication that works by targeting specific receptors involved in the immune system's response. It selectively modulates sphingosine 1-phosphate (S1P) receptors, particularly subtypes 1, 4, and 5. This selective targeting of S1P receptors helps regulate the immune system's activity, potentially reducing inflammation and promoting healing in the gut, crucial for managing UC.

The Phase 3 trial, a multicenter, double-blind, and placebo-controlled study, 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 randomized to receive etrasimod 2mg once daily or placebo for 12 weeks of induction treatment.

Etrasimod treatment resulted in significant improvement in the primary endpoint and all key secondary endpoints, including mucosal healing, symptomatic remission, and endoscopic normalization. The safety profile of etrasimod was consistent with previous studies, and no new safety signals were observed. Patients who responded to induction treatment were then re-randomized to receive either etrasimod 2mg once daily or placebo for 40 weeks of maintenance treatment.

Global Recognition and Future Prospects

With the European Medicines Agency's review of etrasimod underway and applications submitted in various countries, the drug's global impact is becoming increasingly apparent.

Everest Medicines plans to quickly advance the late-stage study of etrasimod towards registration filings in China and other Asian markets. The number of UC patients in China is expected to more than double from 2019 to reach approximately one million by 2030, highlighting the need for novel treatments 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.

About Author: Tracy Mokwe

With over 3 years of experience as a medical laboratory scientist and writer, I am passionate about translating complex scientific information into clear and accessible content. My expertise lies in medical sciences, laboratory science and research, digital health, AI, and cybersecurity in healthcare.