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First patient dosed in phase 3 ulcerative colitis trial

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Arena Pharmaceuticals has announced that the first patient has been dosed in the ELEVATE UC 52 trial, according to a company press release.

ELEVATE UC 52, a phase 3 registrational program evaluating etrasimod (APD334, Arena Pharmaceuticals) 2 mg in patients with moderately to severely active ulcerative colitis (UC), is designed as a treat-through trial with a 12-week induction period followed by 40 weeks of maintenance.

“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, a gastroenterologist at GI Specialists of Houston, said in the release. “With 60% to 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,” Preston Klassen, MD, MHS, chief medical officer of Arena Pharmaceuticals, said in the release. “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. Initiating this trial is the next step towards bringing a potential game-changing therapy to UC patients globally.”