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Arena Announces First Subject Dosed in Etrasimod ELEVATE UC 52 Global Phase 3 Trial

June 20, 2019 By americanpharmaceuticalreview
Tag: trial , Arena , First

Arena Pharmaceuticals announced the first subject has been dosed in ELEVATE UC 52, the first of two pivotal trials within the Phase 3 ELEVATE UC registrational program evaluating etrasimod 2 mg in subjects with moderately to severely active ulcerative colitis (UC). ELEVATE UC 52 is a treat-through trial with a 12-week induction period followed by 40 weeks of maintenance. The ELEVATE UC registrational program aims to include more than 40 countries worldwide.

"We are pleased to enroll the first patient in the ELEVATE UC trial, supporting etrasimod's potential as an important future therapy for ulcerative colitis," said Darshan Anandu, MD, Gastroenterology, G.I. Specialists of Houston. "With 60-80% of patients either not receiving or failing on the current standard of care, there is a clear and significant need for innovative options, especially orally-delivered treatments."

"We are thrilled to announce the first patient dosed in the ELEVATE UC 52 trial. The etrasimod data seen to date are highly encouraging, and we believe represent a clear readthrough to our ELEVATE UC pivotal program, providing us confidence that it will demonstrate clinically meaningful and market-leading evidence of efficacy and safety," said Preston Klassen, MD, MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena. "Initiating this trial is the next step towards bringing a potential game-changing therapy to UC patients globally. We are very grateful to the patients who have participated in etrasimod clinical trials thus far, and to the many additional patients who will enroll in the ELEVATE UC program. We also thank the physicians, medical professionals, and site coordinators, for their continued support."

ELEVATE UC 52 is one of two pivotal trials that are part of the ELEVATE UC global Phase 3 registrational program. ELEVATE UC 52 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. This is a one-year trial evaluating clinical remission at 12 weeks, or induction, and at 52 weeks. The trial consists of a 28-day screening period, a 12-week treatment period, a 40-week treatment period, and a 2-week follow-up period. The primary objective of this trial is to assess the safety and efficacy of etrasimod on clinical remission after both 12 and 52 weeks. The primary endpoint is the FDA-required, 3-domain, modified Mayo Score, which is similar to the primary endpoint in the Phase 2 OASIS study. 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 at time points up to 52 weeks of treatment. The ELEVATE UC program will be conducted in approximately 450 sites across more than 40 countries.

Etrasimod (APD334), is a next generation, oral, selective sphingosine 1 phosphate (S1P) receptor modulator, discovered by Arena, designed to provide systemic and local cell modulation by selectively targeting S1P receptor subtypes 1, 4 and 5. Etrasimod has therapeutic potential in immune and inflammatory-mediated diseases such as ulcerative colitis, Crohn's disease, and atopic dermatitis. S1P receptors have been demonstrated to be involved in the modulation of several biological responses, including lymphocyte trafficking from lymph nodes to the peripheral blood. By isolating subpopulations of lymphocytes in lymph nodes, fewer immune cells are available in the circulating blood to effect tissue damage.

Etrasimod is an investigational compound that is not approved for any use in any country.

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