–Clinically meaningful and statistically significant results demonstrated for primary endpoint and key secondary endpoints for the 12-week induction period–
–Etrasimod was well-tolerated and its safety profile was consistent with prior studies–
–Everest will advance the late-stage study as quickly as possible towards registration in China and other Asian markets–
SHANGHAI, Dec. 1, 2023 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, today reported positive topline data results from a multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of moderate-to-severe active ulcerative colitis (UC). Etrasimod has been approved in October 2023 for the treatment of moderately to severely active UC in adults by the U.S. Food and Drug Administration (FDA) as VELSIPITY™.
"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," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "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."
The multicenter, randomized, 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 randomized to receive etrasimod 2mg once-daily or placebo for 12 weeks of induction treatment. 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 normalization) after the 12-week induction treatment period. In general, treatment with etrasimod 2mg was well tolerated. The safety profile was consistent with previous etrasimod studies and no new safety findings were observed. Patients who responded to induction treatment were then re-randomized to receive 2mg once-daily etrasimod or placebo maintenance treatment for 40 weeks.
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.
Pfizer reported in 2022 the detailed results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12); Phase 3, multi-center, randomized, placebo-controlled trials that evaluated etrasimod in patients with moderately-to-severely active UC. In ELEVATE UC 12, clinical remission was 26.0% for patients receiving etrasimod compared to 15.0% for patients receiving placebo at week 12 (11% differential, p=<0.05). In ELEVATE UC 52, clinical remission was 27.0% for patients receiving etrasimod compared to 7.0% for patients receiving placebo at week 12 (20.0% differential, P˂.001) and was 32.0% compared to 7.0% at week 52 (26.0% differential, P=˂.001).
About Etrasimod
Etrasimod is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory applications for VELSIPITY in ulcerative colitis have been submitted to countries around the world for review, including Canada, Australia, Mexico, Russia, Switzerland, and Singapore. The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for etrasimod, with a decision anticipated in the beginning of 2024.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.
Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.
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