Everest Medicines Presents Complete Maintenance Period Data for Etrasimod at ECCO 2025
- Data confirms significant clinical and endoscopic benefits of etrasimod 2mg after 40 weeks of maintenance treatment
- Etrasimod demonstrates robust efficacy across multiple endpoints, including mucosal healing, endoscopic normalization, and histological remission
- Safety profile remains consistent with previous studies, with no new safety findings were observed
SHANGHAI, Feb. 26, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced the presentation of maintenance data from its multi-center Phase III clinical study of etrasimod (VELSIPITY®) in Asia at the 20th European Crohn's and Colitis Organization Congress (ECCO 2025).
Etrasimod, a next-generation, once-daily selective sphingosine-1-phosphate (S1P) receptor modulator, is being developed for the treatment of moderately to severely active ulcerative colitis (UC). To date, etrasimod is the only advanced UC therapy that has completed a large-scale, randomized, controlled pivotal study in the Asia-Pacific region. The findings of the ES101002 study provide robust evidence supporting the use of etrasimod in UC patients.
The positive results come from a multicenter, randomized, double-blind, placebo-controlled Phase 3 study of etrasimod conducted in the Asian region. This is the largest pivotal Phase 3 study to date in Asian population with moderately to severely active ulcerative colitis. A total of 340 eligible patients with an inadequate response to, loss of response to, or intolerance to at least 1 prior UC treatment were randomized in a 2:1 ratio to receive either etrasimod 2mg once daily or placebo for 12 weeks in the induction period. All patients who completed the induction treatment and were responders at week 12 entered a 40-week maintenance period in which patients were re-randomized in a 1:1 ratio to receive etrasimod 2mg once-daily or placebo for up to 40 weeks.
The results demonstrate that treatment with etrasimod 2 mg resulted in a clinically meaningful and statistically significant improvement in the primary and all secondary endpoints at the end of maintenance period. A statistically significant greater proportion of etrasimod-treated patients achieved clinical remission at Week 40 compared with placebo (etrasimod: 48.1%; placebo: 12.5%; difference = 35.9%; 95% CI: [22.5%, 49.2%]; 2-sided p value < 0.0001). A statistically significant greater proportion of etrasimod-treated patients achieved endoscopic improvement (etrasimod: 61.0%; placebo: 15.0%, difference = 46.6% [95% CI : 33.2%，60.1%], 2-sided p value < 0.0001) and clinical response (etrasimod: 79.2%; placebo: 35.0%, difference = 45.6% [ 95% CI :31.9%，59.3%], 2-sided p value < 0.0001) at week 40 compared with placebo. Other secondary endpoints of mucosal healing, endoscopic normalization, and histological remission also significantly favored patients treated with etrasimod compared with placebo. Notably, mucosal healing as measured by a central read endoscopic subscore≤ 1 (excluding friability) with a Geboes Index score < 2.0, was achieved in 51.9% of the etrasimod treated patients compared to 8.8% in the placebo group (2-sided p-value <0.0001). The safety profile of etrasimod during the maintenance period was consistent with previous studies, with no new safety findings observed.
"The positive results of etrasimod's maintenance data presented at one of the world's leading academic conferences on inflammatory bowel disease further confirms its advantages as an innovative therapy for UC," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Autoimmune diseases have always been a key research focus for Everest. We are committed to enhancing the accessibility and clinical application of etrasimod, and moving forward, we aim to expand its availability across Asia to benefit more appropriate patients."
"As the only drug that has been proven to be effective in UC patients with moderately to severely active isolated proctitis in the global Phase III ELEVATE clinical trials, in the results of the Asian multi-center Phase 3 clinical trial of etrasimod for the treatment of moderately to severely active UC, etrasimod achieved positive topline data results in both the induction and maintenance treatment periods." said Prof. Wu Kaichun at the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod's Asia clinical trial."As a next-generation selective S1P receptor modulator, once-daily oral etrasimod has a rapid onset of action, significantly increases the proportion of patients with clinical remission，endoscopic normalization and mucosal healing, and helps patients to reach their treatment goals sooner. We look forward to more patients with ulcerative colitis benefiting from etrasimod in the future."
As a core product of Everest Medicines, etrasimod is an innovative and advanced therapy that provides rapid onset of action, clinical remission and mucosal healing through an oral, once-daily regimen. Etrasimod has been commercially launched in Macau in 2024. The new drug application has also been officially accepted in mainland China and Hong Kong, and etrasimod has officially been approved for adult patients with moderately to severely active UC by the Guangdong Provincial Medical Products Administration and can be used in the medical institutions designated by the Connect Policy in the Greater Bay Area, The first prescription in mainland Guangdong, Foshan, has been issued for the drug in the Greater Bay Area.
About VELSIPITY® (etrasimod)
VELSIPITY® is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory approvals have been granted in US, EU, Canada, Australia, Singapore, UK, Switzerland, Israel and Macau, China for VELSIPITY® in ulcerative colitis.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, 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
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SOURCE Everest Medicines
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