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Everest Medicines Announces that Licensing Partner Pfizer Reports Positive Topline Results for Phase 3 Trial of Etrasimod in Ulcerative Colitis Patients

March 26, 2022

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.”

About Etrasimod

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.

For further information, please contact:

Investor Relations:
Leah Liu, VP Corporate Affairs
Everest Medicines
IR@everestmedicines.com

Media in US and Europe:
Melissa Roy, Westwicke PR
(203) 682-8285
Melissa.Roy@westwicke.com

Media in Asia:
Jing Yang, Everest Medicines
jing.yang@everestmedicines.com

Forward-Looking Statements:

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

                                

Crohn’s and Colitis Foundation. What is Ulcerative Colitis. Available at: What is Ulcerative Colitis? | Crohn's & Colitis Foundation ( crohnscolitisfoundation.org) Accessed March 18, 2022.

II CSeyedian, SS. A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease. J Med Life 2019 Apr-Jun; 12 (2): 113-122. Available at: A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease - PMC ( nih.gov). Accessed March 22, 2022.

III Hanauer SB. Inflammatory bowel disease. N Engl J Med. 1996;334(13):841-8. Available at: Inflammatory Bowel Disease | NEJM. Accessed March 18, 2022.

IV Irvine EJ. Quality of Life of Patients with Ulcerative Colitis: Past, Present, and Future. Inflammatory Bowel Diseases. 2008;14(4):554-563. Available at: Quality of life of patients with ulcerative colitis: Past, present, and future | Inflammatory Bowel Diseases | Oxford Academic ( openathens.net). Accessed March 18, 2022.

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