Pfizer and Everest Medicines Highlight ELEVATE Phase 3 Trial Results Demonstrating Etrasimod’s Potential as a Best-in-Class Therapy for Ulcerative Colitis

ShanghaiMay 24, 2022PR Newswire -- Everest Medicines' (HKEX 1952.HK) licensing partner, Pfizer Inc. (NYSE: PFE), announced detailed results from two pivotal studies in the ELEVATE UC Phase 3 registration trial at the 2022 Digestive Disease Week (DDW) in the United States. The studies evaluated the efficacy of etrasimod, a once-daily oral selective sphingosine-1-phosphate (S1P) receptor modulator, in treating moderate to severe active ulcerative colitis (UC).

Both of these Phase 3, multicenter, randomized, placebo-controlled studies met all primary and key secondary endpoints, with etrasimod demonstrating safety consistent with previous studies. In the 52-week ELEVATE UC 52 study, the clinical remission rate at week 12 was 27.0% for patients treated with etrasimod, compared to 7.4% for those on placebo (a difference of 19.8%, P=˂.001); at week 52, the clinical remission rate was 32.1% for patients treated with etrasimod, compared to 6.7% for those on placebo (a difference of 25.4%, P=˂.001). In the 12-week ELEVATE UC 12 study, the clinical remission rate was 24.8% for patients treated with etrasimod, compared to 15.2% for those on placebo (a difference of 9.7%, P=.0264).

The 52-week ELEVATE UC 52 study employed a clinical design that closely simulates real-world continuous treatment. All key secondary endpoints of ELEVATE UC 52 demonstrated statistically significant improvements, including endoscopic improvement, symptom relief, and mucosal healing at weeks 12 and 52, as well as corticosteroid-free remission and sustained clinical remission at week 52. The ELEVATE UC 12 study also achieved all key secondary endpoints at week 12, including endoscopic improvement, symptom relief, and mucosal healing.

In the treatment groups of these two studies, treatment-emergent adverse events (AEs, including serious AEs) were similar. By Week 52, the most common treatment-emergent adverse events occurring at a rate of 3% or higher in the etrasimod group compared to the placebo group were headache, UC exacerbation, COVID-19 infection, dizziness, fever, arthralgia, abdominal pain, and nausea. No serious adverse events of bradycardia or atrioventricular block were reported.

Etrasimod was developed by Arena Pharmaceuticals. Pfizer recently completed the acquisition of Arena Pharmaceuticals. In 2017, Everest Medicines obtained exclusive rights from Arena to develop, manufacture, and commercialize etrasimod in Greater China and South Korea. Everest Medicines is currently conducting a Phase 3 clinical trial in Asia for etrasimod in the treatment of moderate to severe active ulcerative colitis, with patient enrollment expected to be completed in 2023.

Dr. Corey Brahm, CEO of Everest Medicines, stated: "The detailed results of the ELEVATE UC Phase 3 program conducted by our partners further demonstrate that etrasimod has the potential to become a best-in-class therapy, which strengthens our confidence in the clinical studies being conducted in Asia. We hope that the trials in Asia will also achieve similarly positive results."

Data from ELEVATE UC 52 and UC 12 are expected to be used for regulatory submissions, with Pfizer anticipating the start of regulatory filings later this year. For more information on these studies, please visitwww.clinicaltrials.gov, with registration numbers NCT03945188, NCT03996369, and NCT03950232.

AboutEtrasimod

Etrasimod is a once-daily oral selective sphingosine-1-phosphate (S1P) receptor modulator that binds to S1P receptors 1, 4, and 5. It is being investigated for the treatment of a range of immune-inflammatory conditions, including ulcerative colitis, Crohn's disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata.

AboutELEVATE UC 52AndELEVATE UC 12

ELEVATE UC 52 and ELEVATE UC 12 are pivotal trials in the ELEVATE UC Phase 3 registration program.

ELEVATE UC 52 is a randomized, double-blind, placebo-controlled trial with a continuous treatment design aimed to evaluate the safety and efficacy of achieving clinical remission after 12 weeks and 52 weeks of once-daily 2mg etrasimod dosing. In this 52-week study, all patients who discontinued from either treatment group were counted as non-responders. The primary endpoint was based on the Modified Mayo Score (MMS) with three components. Key secondary endpoints included endoscopic improvement, symptom resolution, and mucosal healing at weeks 12 and 52, as well as corticosteroid-free remission and sustained clinical remission at week 52.

ELEVATE UC 12 is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of once-daily 2mg etrasimod in patients with moderate to severe active ulcerative colitis. The primary objective of the trial is to assess the safety of etrasimod and its efficacy in achieving clinical remission after 12 weeks of treatment, evaluated based on the modified Mayo score comprising three components required by the FDA. Key secondary endpoints include endoscopic improvement, symptomatic remission, and mucosal healing.

In these two trials, 62.6% of patients receiving etrasimod and 61.8% in ELEVATE UC 52 as well as 62.9% in ELEVATE UC 12 of those receiving placebo had not previously been treated with biologics or JAK inhibitors.

About Ulcerative Colitis

Ulcerative colitis is a chronic, often debilitating inflammatory bowel disease.^[i], with a high global prevalence, an estimated 3.8 million people in North America and Europe are affected by this disease.^[ii], The incidence rate in China and the Asia-Pacific region is increasing year by year, with the incidence rate in China surpassing 11.6 per 100,000 people. Symptoms of the disease may include chronic diarrhea with blood and mucus, abdominal pain, and tenesmus.^[iii],, which can impact the patient's work, family, and social activitiesSignificant Impact^[iv]。

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on the development and commercialization of innovative medicines, dedicated to addressing unmet medical needs in the Asian market. The management team of Everest Medicines has deep expertise and extensive experience in high-quality clinical development, regulatory affairs, chemistry manufacturing and control (CMC), business development, and operations within China and leading global pharmaceutical enterprises. Everest Medicines has built a portfolio of 11 potential first-in-class or best-in-class drugs, most of which are already in the late stages of clinical trials. The company’s therapeutic areas include oncology, autoimmune diseases, cardio-renal diseases, and infectious and contagious diseases. For more information, please visit the company's website:www.everestmedicines.com。

Forward-Looking Statements:

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[i] Crohn's and Colitis Foundation. What is Ulcerative Colitis. See: What is Ulcerative Colitis? | Crohn's & Colitis Foundation (crohnscolitisfoundation.org). Visited on April 26, 2022.

[ii] Seyedian, SS.  A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease.  J Med Life.2019;12(2):113-122. See:A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease - PMC (nih.gov). Accessed on April 26, 2022.

[iii] Hanauer SB.Inflammatory bowel disease.N Engl J Med.1996;334(13):841-8. See:Inflammatory Bowel Disease | NEJM. Accessed on April 26, 2022.

[iv] Irvine EJ. Quality of Life of Patients with Ulcerative Colitis: Past, Present, and Future. Inflammatory Bowel Diseases. 2008;14(4):554-563. See:Quality of life of patients with ulcerative colitis:Past, present, and future | Inflammatory Bowel Diseases | Oxford Academic (openathens.net). Accessed on April 26, 2022.