First Patient Dosed in Phase 3 Trial of Etrasimod for Moderate to Severe UC

First Patient Dosed in Phase 3 Trial of Etrasimod for Moderate to Severe UC
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Etrasimod

The Phase 3 trial ELEVATE UC 52 evaluating Arena Pharmaceuticals’ investigational therapy etrasimod for patients with moderately to severely active ulcerative colitis has dosed its first patient.

“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,” Darshan Anandu, MD, of G.I. Specialists of Houston, said in a press release.

”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,” Anandu said.

Etrasimod works by modulating the selective sphingosine 1 phosphate receptor, which is involved in immune cell recruitment. By modulating the receptor, the treatment reduces the number of immune cells reaching tissues, thus diminishing immune response and inflammation and alleviating symptoms.

The ELEVATE UC 52 trial (NCT03945188), currently recruiting participants, will evaluate the safety and efficacy of etrasimod treatment in moderate or severe cases of ulcerative colitis compared to a placebo. After a 28-day screening period, patients will receive etrasimod as a 2 mg once-daily oral capsule for 12 weeks (induction phase), followed by treatment for 40 weeks (maintenance phase) or a matching placebo.

The aim is to evaluate safety and clinical remission, as assessed by Mayo score components evaluating rectal bleeding, stool frequency, and endoscopy findings, after 12 and 52 weeks.

ELEVATE UC 52 is one of the two Phase 3 studies portion of the ELEVATE UC global Phase 3 registration program.

“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 toward 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,” he said.

Arena Pharmaceuticals expects the trial to be completed by November 2021.

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