NEW YORK, Nov. 14, 2019 (GLOBE NEWSWIRE) -- Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today that the first patient has been dosed in a double-blind, randomized, placebo controlled, multi-center Phase 3 clinical study to evaluate the efficacy and safety of etrasimod for induction and maintenance of treatment in subjects with moderately to severely active ulcerative colitis (UC).
Etrasimod is a next generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator discovered by Arena Pharmaceuticals, Inc. (Nasdaq: ARNA), and designed for optimized pharmacology and engagement of S1P receptor 1, 4 and 5 that may lead to an improved efficacy and safety profile. Etrasimod provides systemic and local effects on specific immune cell types and has the potential to treat multiple immune-mediated inflammatory diseases including UC, Crohn’s disease, and atopic dermatitis. In December 2017, Arena Pharmaceuticals, Inc. granted Everest Medicines an exclusive, royalty-bearing license to develop, manufacture and commercialize etrasimod in Mainland China, Taiwan, Hong Kong, Macau and South Korea. Etrasimod is an investigational compound that is not approved for any use in any country.
“Dosing our first patient in this 52-week phase 3 clinical study is an important step forward in the evaluation of etrasimod as a novel therapy for UC patients with significant unmet needs in China,” said Sean Cao, CEO of Everest Medicines. “The clinical data generated to date and the mechanism of action suggests that etrasimod may become a promising novel oral treatment option for UC patients. We look forward to working with investigators across all clinical sites to complete the study.”
The phase 3 study will enroll approximately 330 patients with moderate-severe UC in Mainland China, South Korea and Taiwan. The primary objective of this study is to demonstrate the efficacy and safety of etrasimod, in subjects with moderately to severely active UC.
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic disease that affects the large intestine. The innermost lining of the large intestine becomes inflamed and ulcers may form on the surface, which can cause symptoms such as frequent bowel movements, diarrhea and bloody stools. The inflammation is usually found in the rectum and can include all or a portion of the colon. Currently available treatment options have limitations in terms of side effects, patient response, efficacy and administration.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. For more information, please visit its website at www.everestmedicines.com.
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View the press release here.