Everest Medicines Announces Publication of Etrasimod's Asian Multicenter Phase III ENLIGHT UC study (ES101002) Results in The Lancet Gastroenterology & Hepatology
- The published study results are from the ENLIGHT UC study (ES101002), a multicenter, randomized, double-blind and placebo-controlled Phase III trial of etrasimod conducted across Asia. The study included a 12-week induction phase followed by a 40-week maintenance phase and represents the largest pivotal Phase III study to date in Asian patients with moderately to severely active ulcerative colitis.
- The study results showed that, during both the 12-week induction phase and the 40-week maintenance phase, etrasimod demonstrated statistically significant and clinically meaningful improvements across all primary and secondary efficacy endpoints.
- Currently, only around 24% of patients achieve mucosal healing with available treatments. Results from the ENLIGHT UC study demonstrated that after 52 weeks of etrasimod treatment, the mucosal healing rate reached 51.9%, with a mucosal normalization rate of 45.5%.
- The safety profile of etrasimod was consistent with previous studies, with no new safety signals observed.
SHANGHAI, Oct. 9, 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 that the results of its Asian multicenter Phase III ENLIGHT UC study (ES101002) of etrasimod (VELSIPITY®) for the treatment of moderately to severely active ulcerative colitis (UC), have been published in the prestigious international journal The Lancet Gastroenterology & Hepatology, marking the global recognition of this next-generation selective S1P receptor modulator's efficacy in Asian patients.
ENLIGHT is the largest Phase III trial of moderately to severely active ulcerative colitis in Asia completed to date, with 340 eligible subjects randomized to treatment with etrasimod or placebo. Patients with inadequate response or intolerance to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy were randomized to receive etrasimod once-daily or placebo for 12 weeks of induction treatment. Patients who had completed 12-week of induction treatment and responded were re-randomized into the 40-week maintenance period to receive once-daily etrasimod or placebo.
The primary efficacy endpoints were the proportions of patients achieving clinical remission at Week 12 (induction) and Week 40 (maintenance). The key secondary endpoints of the study were the proportion of patients achieving endoscopic improvement and clinical response at Week 12 (induction) and at Week 40 (maintenance).
The study results showed that, during both the 12-week induction phase and the 40-week maintenance phase, etrasimod demonstrated statistically significant and clinically meaningful improvements across all primary and secondary efficacy endpoints.
A significantly greater proportion of patients treated with etrasimod than those treated with placebo showed clinical remission at induction week 12 (57 [25.0%] of 228 patients vs 6 [5.4%] of 112 patients; adjusted difference 20.4%, 95% CI 13.4–27.4, p<0.0001) and maintenance period week 40 (37 [48.1%] of 77 patients vs 10 [12.5%] of 80 patients; adjusted difference 35.9%, 95% CI 22.5–49.2, p<0.0001).
At induction period week 12, a significantly greater proportion of patients treated with etrasimod than those treated with placebo showed endoscopic improvement (85 [37.3%] of 228 patients treated with etrasimod vs 11 [9.8%] of 112 patients treated with placebo; adjusted difference 28.6%, 95% CI 20.5–36.7, p<0•0001) and clinical response (133 [58.3%] of 228 patients treated with etrasimod vs 31 [27.7%] of 112 patients treated with placebo; adjusted difference 32.0%, 95% CI 21.8–42.2, p<0•0001).
At maintenance period week 40, a significantly greater proportion of patients treated with etrasimod than those treated with placebo showed endoscopic improvement (47 [61.0%] of 77 patients treated with etrasimod vs 12 [15.0%] of 80 patients treated with placebo; adjusted difference 46.6%, 95% CI 33.2–60.1, p<0•0001) and clinical response (61 [79.2%] of 77 patients treated with etrasimod vs 28 [35.0%] of 80 patients treated with placebo; adjusted difference 45.6%, 95% CI 31.9–59.3, p<0•0001). 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 (p<0.0001). The safety profile of etrasimod during the maintenance period was consistent with previous studies, with no new safety findings observed.
Prof. Wu Kaichun at the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod's Asia clinical trial said: "The internationally renowned journal The Lancet Gastroenterology & Hepatology recently published the results of the multicenter Phase III ENLIGHT UC study (ES101002) of etrasimod in patients with moderately to severely active UC in Asia, marking the global academic recognition of the research findings of this next-generation selective S1P receptor modulator in Asian patients.
Previously, there was limited high-quality data for moderately to severely UC in Asia. As the largest Phase III trial of UC in Asia, the results fill the gap in clinical data on active UC in Asia. The results confirms that etrasimod shows good efficacy and safety in Asian patients including Chinese patients, with positive effects on improving clinical symptoms and promoting endoscopic improvement. We look forward to etrasimod benefiting more ulcerative colitis patients in the future."
"Publication of the ENLIGHT UC study in The Lancet Gastroenterology & Hepatology underscores etrasimod's strong clinical value in the treatment of moderately to severely active UC and providing stronger clinical evidence to support patients across Asia." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "In Asia, the number of UC patients continues to rise, while treatment options remain limited, highlighting an urgent need for innovative therapies that balance efficacy, safety, and convenience. In China alone, the UC patient population is estimated at approximately 800,000 in 2024 and projected to reach 1.5 million by 2031.
To ensure patient access in China and across Asia, the company initiated local production of etrasimod in March and remains committed to accelerating the regulatory approval process in Mainland China and other Asian markets, helping more patients achieve higher-quality, longer-lasting disease remission."
VELSIPITY® has been approved in Singapore, Macao SAR, and Hong Kong SAR. Its NDA has also been accepted in South Korea and Taiwan, China. In December 2024, China's National Medical Products Administration (NMPA) officially accepted the NDA for VELSIPITY®, with approval expected in the first half of 2026. As Everest's third commercialized product, VELSIPITY® has been approved by the Guangdong Provincial Medical Products Administration for adult patients with moderately to severely active UC, and is now available at medical institutions designated under the Connect Policy in the Greater Bay Area. The localized production project for VELSIPITY® was officially launched at the Jiashan manufacturing site in March 2025, providing strong support for its future commercialization.
As a core product of Everest Medicines, etrasimod is an innovative and advanced therapy that provides rapid onset of action, clinical remission and endoscopic improvement through an oral, once-daily regimen. Following its inclusion in the American Gastroenterological Association (AGA) Clinical Practice Guideline as a first-line treatment for ulcerative colitis in December 2024, etrasimod was included in the American College of Gastroenterology (ACG) Clinical Guideline Update in June 2025, strongly recommended for both induction and maintenance of remission in patients with moderately to severely active UC.
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, Japan, Australia, Singapore, UK, Switzerland, Israel, Hong Kong SAR, and Macao SAR, China for VELSIPITY® in ulcerative colitis, as well as additional countries.
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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