Everest Medicines Achieved First Patient Dosing Milestone in Etrasimod Phase 3 Clinical Study in Ulcerative Colitis Patients ...
November 14 2019 - 9:00AM
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.
Contacts:
Media in US and Europe: Mark Corbae Senior Vice
President Westwicke PR +1 (203) 682-8288 mark.corbae@icrinc.com
Media in China: Edmond Lococo Senior Vice President ICR Asia +86
(10) 6583-7510 edmond.lococo@icrinc.com
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