Everest Medicines' Etrasimod: A Promising UC Treatment with Robust Efficacy and Safety Profile

Everest Medicines, a biopharmaceutical company focused on developing innovative therapeutics, has presented complete maintenance period data for its next-generation, once-daily selective sphingosine-1-phosphate (S1P) receptor modulator, etrasimod (VELSIPITY®), at the 20th European Crohn's and Colitis Organization Congress (ECCO 2025). The positive results from the ES101002 study provide robust evidence supporting the use of etrasimod in patients with moderately to severely active ulcerative colitis (UC).

The multicenter, randomized, double-blind, placebo-controlled Phase 3 study of etrasimod was conducted in the Asian region, involving 340 eligible patients with an inadequate response to, loss of response to, or intolerance to at least one prior UC treatment. Patients 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 the 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 from the ES101002 study further confirm etrasimod's advantages as an innovative therapy for UC, with robust efficacy across multiple endpoints, including clinical remission, endoscopic improvement, and mucosal healing. The consistent safety profile observed during the maintenance period also supports the drug's potential as a safe and well-tolerated treatment option for UC patients. Everest Medicines is committed to enhancing the accessibility and clinical application of etrasimod, and plans to expand its availability across Asia to benefit more appropriate patients.

In conclusion, the complete maintenance period data for etrasimod presented at ECCO 2025 demonstrate the drug's robust efficacy and safety profile in treating patients with moderately to severely active UC. As a next-generation, once-daily, oral selective S1P receptor modulator, etrasimod offers a convenient and potentially more effective alternative to existing UC treatments. With its positive results and consistent safety profile, etrasimod has the potential to become a significant player in the UC treatment market in Asia, challenging the dominance of existing therapies and providing a new option for patients and healthcare providers.