Everest Medicines announced that Department of Health of the Government of the Hong Kong Special Administrative Region, China, has accepted Everest's New Drug Application (NDA) for VELSIPITY (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis. 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., and other countries, by Everest's licensing partner, Pfizer. In Everest territories, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China has approved the NDA for VELSIPITY in April of this year and was implemented in the Guangdong-Hong Kong-Macau Greater Bay Area this October through the "Hong Kong and Macau Medicine and Equipment Connect" policy.

The acceptance of the NDA 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 with moderately to severely active UC 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 ELE VELSIPITY®? were naive 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 conducted a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian countries, including mainland China, China Taiwan and South Korea. 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.

The previously announced results of the induction period indicate that the clinical remission rate for patients treated with etrasimod 2mg was 25.0%, compared to 5.4% for those treated with placebo (difference 20.4%, p<0.0001). Compared to the placebo group, patients treated with etrasimod demonstrated significant clinical and statistically significant improvements in all key secondary endpoints. Subsequently, the topline results from maintenance period released in July of this year 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<0.0001), and other secondary endpoints (including mucosal healing and endoscopic normalization, both p<0.0001).

The safety profile of etrasimod was consistent with previous studies, with no new safety signals observed. The results of the maintenance period will be released at an international academic conference.