Arena Announces First Subject Dosed Etrasimod Trial for Ulcerative Colitis

Arena Pharmaceuticals announced the first subject has been dosed in the ELEVATE UC 12 global Phase 3 trial evaluating etrasimod, an investigational, next-generation, once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator, for the potential treatment of moderately to severely active ulcerative colitis. ELEVATE UC 12 is the second of two pivotal trials within the Phase 3 ELEVATE UC registrational program to assess the safety and efficacy of etrasimod 2 mg.

"The enrollment of the first patient in ELEVATE UC 12 is an important milestone in the development of etrasimod, an oral, once-daily option, with a novel mechanism of action," said Timothy Ritter, MD, Senior Medical Director, Department of Clinical Research and Education, GI Alliance Research. "There is a significant unmet need for patients with moderate to severe ulcerative colitis, and I look forward to seeing the results of Arena's Phase 3 program."

"We are pleased to initiate the ELEVATE UC 12 Phase 3 trial, the second of two pivotal trials that will bring us one step closer to our goal of delivering an oral, once-daily, durable therapeutic option for patients living with ulcerative colitis," said Chris Cabell, MD, MHS, FACC, Executive Vice President, Head of Research and Development, and Chief Medical Officer at Arena. "This is a significant milestone for Arena as the progress confirms that the ELEVATE UC registrational program, including ELEVATE UC 12 and UC 52 trials, remains on track for data by year-end 2021."

ELEVATE UC 12 is one of two pivotal trials that are part of the ELEVATE UC global Phase 3 registrational program. ELEVATE UC 12 is a 2:1 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 ulcerative colitis (UC) defined as a baseline 3-domain, modified Mayo Score of 4 to 9 with an endoscopic score of 2 or more, and a rectal bleeding score of 1 or more. The primary objective of this trial is to assess the safety and efficacy of etrasimod on clinical remission at 12 weeks assessed by the FDA-required, 3-domain, modified Mayo Score, which is similar to the primary endpoint in the Phase 2 OASIS trial. Key secondary measures include the efficacy of etrasimod on clinical response, symptomatic response and remission, endoscopic changes, corticosteroid-free remission, and a total healing in these subjects. The ELEVATE UC program is being conducted in approximately 450 sites across more than 40 countries.

Etrasimod (APD334) is a next generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator discovered by Arena, and designed for optimized pharmacology and engagement of S1P receptor 1, 4 and 5 which may lead to an improved efficacy and safety profile.

Etrasimod provides systemic and local effects on specific immune cell types and has the potential to treat multiple immune-mediated inflammatory diseases, including ulcerative colitis, Crohn's disease, atopic dermatitis, and alopecia areata.