PR Newswire - Everest Medicines Announces New Drug Application Approval of VELSIPITY® for Adults with Moderately to Severely Active Ulcerative Colitis in Macau

SHANGHAI, May 8, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China has approved the New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). It marks the first approval of VELSIPITY® in Everest territories. VELSIPITY® 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., 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.

"We are delighted that the VELSIPITY® NDA submission has been approved in Macau, China," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Autoimmune disease is a core focus and a significant growth driver for our company. 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. Leveraging the preferential policies in the Greater Bay Area, we're poised to accelerate drug accessibility for mainland China. The company plans to submit the NDA for approval by China's National Medical Products Administration (NMPA) this year, with the aim of benefiting more Chinese patients as soon as possible."

"This approval in Macau is an important milestone for etrasimod, which is expected to benefit patients in Asia, and especially in Greater China in the near future. VELSIPITY® has a favorable benefit-risk profile," said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod's Asia clinical trial. "As a next-generation S1P receptor modulator, VELSIPITY® can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief. As of now, the clinical data from our Phase 3 Asia clinical trial shows that a positive top line result has been achieved after the 12-week induction treatment period. We hope Greater China and other Asian countries can obtain approvals as soon as possible to benefit more patients."

The approval was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of etrasimod 2 mg once-daily on clinical remission in UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12 were naïve to biologic or JAK inhibitor therapy, and these studies were also the only studies for advanced therapies for ulcerative colitis to include patients with isolated proctitis. Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod.

Everest is conducting a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian countries, including mainland China, China Taiwan and South Korea. Patients with inadequate response or intolerance to at least one conventional, biologic, or JAK inhibitor therapy were randomized to receive etrasimod 2mg once-daily or placebo for 12 weeks of induction treatment. Etrasimod treatment resulted in a clinically meaningful and statistically significant improvement in the primary endpoint and all key secondary and other secondary endpoints (including mucosal healing, symptomatic remission and endoscopic normalization) after the 12-week induction treatment period. In general, treatment with etrasimod 2mg was well tolerated. The safety profile was consistent with previous etrasimod studies and no new safety findings were observed. Patients who responded to induction treatment were then re-randomized to receive 2mg once-daily etrasimod or placebo maintenance treatment for 40 weeks. The data for maintenance period is expected for readout in 2H 2024.

About VELSIPITY® (etrasimod)

VELSIPITY® is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory applications for VELSIPITY® in ulcerative colitis have been submitted to additional countries including Australia, India, Mexico, Russia, Singapore, Switzerland, Turkey, Israel and Brazil.

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 comprising of a 12-week induction period followed by a 40-week maintenance period. Subjects were randomized to VELSIPITY or placebo and continued on treatment without re-randomization for the entire duration of the study. Beginning at week 12, all patients could continue their randomized treatment; patients whose disease had not improved or had worsened compared to baseline could discontinue and, if eligible, enroll in an open-label extension study. 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. The primary endpoint is based on the 3-domain, modified Mayo score (MMS). In ELEVATE UC 52, clinical remission was 27.0% for patients receiving etrasimod compared to 7.0% for patients receiving placebo at week 12 (20.0% differential, P˂0.001) and was 32.0% compared to 7.0% at week 52 (26.0% differential, P˂0.001). Statistically significant improvements were attained in all key secondary endpoints, including endoscopic improvement 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, MMS. In ELEVATE UC 12, clinical remission was achieved among 26.0% of patients receiving etrasimod compared to 15.0% of patients receiving placebo (11.0% differential, P <0.05). All key secondary endpoints were met at week 12, including endoscopic improvement and mucosal healing.

In ELEVATE UC 12, a similar proportion of patients experienced treatment-emergent adverse events (AEs) between etrasimod 2 mg and placebo treatment groups, while in ELEVATE UC 3 52, it was higher in the etrasimod 2 mg group compared to placebo. The proportion of patients experiencing serious AEs was 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, elevated liver tests, worsening of UC, COVID-19 infection, dizziness, pyrexia, arthralgia, abdominal pain and nausea. Data support that initiation of etrasimod treatment does not require a complex up-titration regimen.

Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12, respectively, were naïve to biologic or JAK inhibitor therapy.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines 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 from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com. 

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