Everest Medicines Announces that Licensing Partner Pfizer Reports Positive Topline Results for Phase 3 Trial of Etrasimod in Ulcerative Colitis Patients
Shanghai, China—March 26, 2022 — Everest Medicines (HKEX 1952.HK) announced today that its licensing partner, Pfizer Inc. (NYSE: PFE), reports positive topline results from a global Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC).
In the multi-center, randomized, double-blind, placebo-controlled study, also known as ELEVATE 12, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo. Statistically significant improvements were achieved in all key secondary endpoints in the trial as well. The safety profile was consistent with previous Phase 2 studies.
The study enrolled 354 UC patients who had previously failed or were intolerant to at least one conventional, biologic, or JAK therapy. Participants received etrasimod 2mg once daily. Full results from the study will be submitted for future scientific publication and presentation. These data along with results from ELEVATE 52 are expected to form the basis for planned future regulatory filings. Results from the ELEVATE 52 study are expected to be available by the end of first quarter. Etrasimod was developed by Arena Pharmaceuticals, which was recently acquired by Pfizer, and Everest Medicines secured exclusive rights from Arena to develop, manufacture and commercialize etrasimod in Greater China and South Korea in 2017.
Everest Medicines is conducting a phase 3 study for etrasimod in Asia for the treatment of moderate-severe ulcerative colitis, which is expected to complete enrollment in 2023.
“We congratulate our partner for the encouraging topline results which take etrasimod an important step closer to becoming a promising novel treatment option for UC patients,” said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. “We are moving our phase 3 study in Asia forward as planned and hope to demonstrate that the Asian population matches global results.”
Etrasimod is an oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator being investigated for a range of immuno-inflammatory diseases including ulcerative colitis, Crohn’s Disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata.
In a Phase 2, randomized, placebo-controlled, dose-ranging study (OASIS) in moderate to severe UC patients, most patients who achieved clinical response, clinical remission, or endoscopic improvement at week 12 experienced sustained or improved effects up to week 46, with etrasimod 2 mg in the open-label extension. Etrasimod also demonstrated a favorable benefit/risk profile, consistent with safety findings reported in the double-blind portion of OASIS.
About Ulcerative Colitis
UC is a chronic and often debilitating inflammatory bowel disease that affects many people worldwide, including an estimated 3.8 million people in North America and Europe. Symptoms of UC can include chronic diarrhea with blood and mucus, abdominal pain and cramping, and weight loss. UC can have a significant effect on work, family and social activities.
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 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. Everest Medicines has built a portfolio of eleven potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
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Leah Liu, VP Corporate Affairs
Media in US and Europe:
Melissa Roy, Westwicke PR
Media in Asia:
Jing Yang, Everest Medicines
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