Everest Medicines Presents Complete Maintenance Period Data for Etrasimod at ECCO 2025
Wednesday, 26 February 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, China – February 26, 2025 – 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
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