Everest Medicines Announces Positive Topline Results from Maintenance Period of Etrasimod Phase 3 Clinical Trial Conducted in Asia for the Treatment of Moderately-to-Severely Active Ulcerative Colitis
Monday, 15 July 2024 ()
Shanghai, China – July 15^th, 2024—Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery , clinical development, manufacturing and commercialization of innovative therapeutics, today announced positive topline data results of the maintenance period from a multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of subjects with moderately-to-severely active ulcerative colitis (UC). VELSIPITY^® (etrasimod) is an effective and convenient, once-daily, oral treatment for patients with moderately-to-severely active UC that has already been approved in the U.S. and E.U., and other countries, by Everest’s licensing partner, Pfizer. VELSIPITY^® is the first and only advanced oral UC therapy approved for use in patients 16 years of age or older in the EU. In Everest territories, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China has approved the New Drug Application (NDA) for VELSIPITY^® in April of this year.
“These positive results are both clinically meaningful and statistically significant, which further demonstrate that etrasimod has the potential to be a breakthrough option for patients with moderately-to-severely active UC " said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “The number of UC patients in China is projected to double from 2019 to approximately one million by 2030, highlighting the urgent need for novel treatments. Etrasimod is expected to provide a new oral therapy option with a favorable benefit-risk profile for UC patients. Autoimmune disease is a key therapeutic focus for Everest. We plan to submit an NDA to China’s National Medical Products Administration this year to benefit more Chinese patients as soon as possible.”
The positive results are from a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod 2mg conducted in Asian countries. This is the largest Phase 3 trial of moderately-to-severely active ulcerative colitis in Asia completed to date, with 340 eligible subjects randomized to treatment with etrasimod or placebo. Patients with inadequate response or intolerance to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy were randomized to receive etrasimod 2mg once-daily or placebo for 12 weeks of induction treatment. Patients who had completed 12- week of induction treatment and responded to induction treatment were re-randomized into the 40-week maintenance period to receive 2mg once-daily etrasimod or placebo.
The primary efficacy endpoints for the induction period and maintenance period were the proportions of patients achieving clinical remission at Induction Week 12 and Maintenance Week 40, respectively. The key secondary endpoints of the study were the proportion of patients achieving endoscopic improvement and clinical response at Week 12 for the induction phase and at Week 40 for the maintenance phase. Safety was assessed throughout the study, with treatment-emergent adverse events (TEAEs) graded by the Common Terminology Criteria for Adverse Events (CTCAE).
The data of maintenance treatment confirmed that, after 40 weeks of treatment, etrasimod demonstrated significant clinical and statistical improvements over placebo in the primary and all key secondary endpoints (p
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