- The data confirm the important clinical and endoscopic advantages of the 2 mg etrarasimod after 40 weeks of maintenance treatment
- Etrasimod demonstrates robust efficiency on several evaluation criteria, including mucous healing, endoscopic normalization and histological remission
- The security profile remains consistent with previous studies, without new security results having been observed
Shanghai,, February 26, 2025 / Prnewswire / – Everest Medicines (Hkex 1952.hk, “Everest”, or “Company”), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and marketing of innovative therapies, announced today the presentation Maintenance data from its multicentric clinical study of Phase III of Etrasimod (Velsipity®) Asia At the 20th European Congress in Crohn and Colitis Congress (ECCO 2025).
Etrasimod, a new generation sphosphate receiver receiver and once a day, is under development for the treatment of moderately to severe ulcerative colitis (UC). To date, Etrasimod is the only advanced UC therapy that has completed a large -scale randomized pivotal study in the Asia-Pacific region. The results 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 and controlled by placebo study, of the etrasimod carried out in the Asian region. This is the largest pivotal study in phase 3 to date in the Asian population with a moderately active ulcerative colitis. A Total of 340 Eligible Patients With An Inadequate Response To, Loss of Response To, or Insolance to At Least 1 Prior Uc Treatment Were Randomized In A 2: 1 Ratio to Receive EITHER ETRASIMOD 2MG OCE DAILY OR PLAC . All patients who finished the induction treatment and were respondents in week 12 entered a 40-week maintenance period during which the patients were re-handled in a 1: 1 ratio to receive Etrasimod 2 mg once a day or a placebo for up to 40 weeks.
The results show that treatment with Etrasimod 2 mg has caused clinically significant and statistically significant improvement in primary and secondary evaluation criteria at the end of the maintenance period. A greater statistically significant proportion of patients treated with EtraSimod has obtained clinical remission for week 40 compared to placebo (EtraSimod: 48.1%; placebo: 12.5%; difference = 35.9%; 95%CI :: [22.5%, 49.2%]; Value p 2 faces <0.0001). A greater statistically significant proportion of patients treated with the Etrasimod has reached an endoscopic improvement (Etrasimod: 61.0%; placebo: 15.0%, difference = 46.6% [95% CI : 33.2%，60.1%]Value P 2 Faces <0.0001) and clinical response (EtraSimod: 79.2%; placebo: 35.0%, difference = 45.6% [ 95% CI :31.9%，59.3%]Value P 2 Faces <0.0001) at week 40 compared to placebo. Other secondary evaluation criteria of mucous healing, endoscopic normalization and histological remission have also significantly favored patients treated with Etrasimod compared to placebo. In particular, the mucous healing measured by an endoscopic basement at central reading ≤ 1 (excluding friability) with a geboes index score <2.0 value <0.0001). Etrasimod's safety profile during the maintenance period was consistent with previous studies, without new security results observed.
“The positive results of the Etrasimod maintenance data presented during one of the main academic conferences in the world on the inflammatory intestine disease also confirms its advantages as innovative therapy for the CU”, said Rogers Yongqing LuoManaging Director of Everest Medicines. “Autoimmune diseases have always been a key orientation for Everest. We are committed to improving accessibility and clinical application of Etrasimod, and in the future, we aim to extend its availability through Asia To benefit more appropriate patients. “”
“As the only medication that has proven to be effective in patients with CU with moderately active isolated protity in the world phase III of clinical trials, in the results of the phase 3 asian clinical trial Multi-center egstimods for the treatment of treatment for treatment for treatment for treatment for treatment for treatment of treatment for treatment for treatment for treatment for treatment for treatment for treatment for treatment for treatment for treatment for treatment for treatment for treatment for treatment for treatment of multicentric multicentric UC moderately to severely Active, the etrasimod has obtained positive topline data which translates both in the periods of induction and maintenance treatment. Professor Wu Kaichun at the first AFMU affiliated hospital which is the main investigator for Etrasimod Asia Clinical trial.“As a new generation selective S1P receptor modulator, Oral Etrasimod Once a day has a rapid start of action, considerably increases the proportion of patients with clinical remission ， Endoscopic normalization and mucous healing, and helps patients to reach Their treatment objectives earlier. of Étrasimod in the future.
As a basic product of Everest drugs, Etrasimod is an innovative and advanced therapy that provides a rapid appearance of action, clinical remission and mucous healing by an oral diet once a day. Etrasimod was launched commercially in Macao In 2024. The new drug request was also officially accepted on the continent China And Hong KongAnd Etrasimod was officially approved for adult patients with moderately active CU by the provincial medical product Guangdong Products Administration and can be used in medical institutions designated by connection policy in the Grande Baie region, the first prescription in continent GuangdongFoshan was issued for the medication in the Grand Bay region.
About Velsipity® (EtraSimod)
Bike® is a 1-phosphate (S1P) receiver (S1P) receptor modulator once a day which is selective with the subtypes of S1P 1, 4 and 5 receptor subtypes have been granted to the United States, EU, EU, Canada,, Australia,, SingaporeUNITED KINGDOM, Swiss,, Israel And Macao,, China For Velsipity® in ulcerative colitis.
On Everest drugs
Everest Medicines is a biopharmaceutical company focused on the discovery, development, manufacture and marketing of transformer pharmaceuticals and vaccines that meet critical medical needs not satisfied for patients on Asian markets. The management team of Everest Medicines has in -depth expertise and in -depth experience of the main global pharmaceutical companies and local Chinese pharmaceutical companies in high quality discovery, clinical development, regulatory affairs, CMC, commercial development and operations. Everest Medicines has built a portfolio of first-rate molecules or the best in potentially global class in the main therapeutic areas of the society of kidney diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com
Prospective declarations:
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