SHANGHAI, May 24, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK) announced today that its licensing partner, Pfizer Inc. (NYSE: PFE) presented at Digestive Disease Week (DDW) 2022 detailed results from two pivotal studies that make up the ELEVATE UC Phase 3 registrational program evaluating etrasimod, a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator for the treatment of moderately-to-severely active ulcerative colitis (UC).
Both Phase 3, multi-center, randomized, placebo-controlled trials achieved all primary and key secondary endpoints, with etrasimod demonstrating a safety profile consistent with previous studies. In the 52-week ELEVATE UC 52 study, clinical remission was 27.0% for patients receiving etrasimod compared to 7.4% for patients receiving placebo at week 12 (19.8% differential, P=˂.001) and was 32.1% compared to 6.7% at week 52 (25.4% differential, P=˂.001). In the 12-week ELEVATE UC 12 study, clinical remission was achieved among 24.8% of patients receiving etrasimod compared to 15.2% of patients receiving placebo (9.7% differential, P=.0264).
The 52-week ELEVATE UC 52 trial utilized a treat-through design which closely mimics real-world clinical practice. Statistically significant improvements were attained in all key secondary endpoints in ELEVATE UC 52. These included endoscopic improvement, symptomatic remission, and mucosal healing at weeks 12 and 52, and corticosteroid-free remission and sustained clinical remission at week 52. All key secondary endpoints were also met at week 12 in ELEVATE UC 12. These included endoscopic improvement, symptomatic remission, and mucosal healing.
Treatment-emergent adverse events (AEs), including serious AEs, were similar between treatment groups in both trials. The most common treatment-emergent AEs in 3% or more of etrasimod-treated patients and greater than placebo up to week 52 in either trial were headache, worsening of UC, COVID-19 infection, dizziness, pyrexia, arthralgia, abdominal pain and nausea. There were no reports of bradycardia or atrioventricular block as serious AEs.
Etrasimod was developed by Arena Pharmaceuticals, which has recently been acquired by Pfizer. Everest Medicines obtained 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 moderately-to-severely active ulcerative colitis, which is expected to complete enrollment in 2023.
"The detailed results from our partner's ELEVATE UC Phase 3 program further demonstrate etrasimod's potential as a best-in-class therapy," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "This adds to our confidence in our Asia clinical trial, where we hope to see similar positive results."
The data from ELEVATE UC 52 & UC 12 are expected to form the basis for planned future regulatory filings, which Pfizer expects to initiate later this year. Additional information about the studies can be found at www.clinicaltrials.gov under the identifiers NCT03945188, NCT03996369, and NCT03950232.
About Etrasimod
Etrasimod is an oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator designed for optimized pharmacology and engagement of S1P receptors 1, 4, and 5. It is being investigated for a range of immuno-inflammatory diseases, including ulcerative colitis, Crohn's disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata.
About ELEVATE UC 52 and ELEVATE UC 12
ELEVATE UC 52 and ELEVATE UC 12 are pivotal trials that are part of the ELEVATE UC Phase 3 registrational program.
ELEVATE UC 52 is a randomized, double-blind, placebo-controlled trial that utilized a treat-through design. The primary objective of this trial was to assess the safety and efficacy of etrasimod 2 mg once-daily on clinical remission after both 12 and 52 weeks. All patients that dropped out of the study across either treatment arm over the 52-week study were counted as non-responders. The primary endpoint is based on the 3-domain, modified Mayo score (MMS). Key secondary measures included endoscopic improvement, symptomatic remission, and mucosal healing at weeks 12 and 52, and corticosteroid free remission and sustained clinical remission at week 52.
ELEVATE UC 12 is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of etrasimod 2 mg once-daily in subjects with moderately-to-severely active UC. The primary objective of this trial was to assess the safety and efficacy of etrasimod on clinical remission at 12 weeks assessed by the FDA-required, 3-domain, modified Mayo score. Key secondary measures included endoscopic improvement, symptomatic remission, and mucosal healing.
62.6% of etrasimod-treated patients in both trials and 61.8% and 62.9% of placebo-treated patients in ELEVATE UC 52 and ELEVATE UC 12, respectively, were naïve to biologic or JAK inhibitor therapy.
About Ulcerative Colitis
UC is a chronic and often debilitating inflammatory bowel disease[i] that affects many people worldwide, including an estimated 3.8 million people in North America and Europe[ii]. Symptoms of UC can include chronic diarrhea with blood and mucus, abdominal pain and urgency[iii]. UC can have a significant effect on work, family and social activities[iv].
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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[i] Crohn's and Colitis Foundation. What is Ulcerative Colitis. Available at: What is Ulcerative Colitis? | Crohn's & Colitis Foundation (crohnscolitisfoundation.org). Accessed 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. Available at: A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease - PMC (nih.gov). Accessed April 26, 2022. [iii] Hanauer SB. Inflammatory bowel disease. N Engl J Med. 1996;334(13):841-8. Available at: Inflammatory Bowel Disease | NEJM. Accessed 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. Available at: Quality of life of patients with ulcerative colitis: Past, present, and future | Inflammatory Bowel Diseases | Oxford Academic (openathens.net). Accessed April 26, 2022. |
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