Therapy Areas: Inflammatory Diseases
Arena Pharmaceuticals Achieves Target Enrollment for Etrasimod CULTIVATE Study A Evaluating 2 mg and 3 mg Etrasimod in Study Participants with Moderate to Severe Crohn's Disease
19 November 2021 - - US-based Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) has achieved target enrollment in Study A of the Phase 2/3 CULTIVATE trial evaluating the safety and efficacy of etrasimod, a highly selective, once-daily, oral sphingosine 1-phosphate receptor modulator, in participants with moderate to severe Crohn's disease, the company said.

CULTIVATE Study A reached target enrollment of 70 study participants to assess etrasimod 2 mg and 3 mg in participants with CD.

CULTIVATE is a Phase 2/3 trial consisting of five studies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderate to severe Crohn's disease who are refractory or intolerant to at least one of the current therapies for CD.

CULTIVATE is being conducted in approximately 27 countries globally.

CULTIVATE Study A is a Phase 2 randomized, double-blind trial to assess the efficacy, safety, and tolerability of etrasimod 2 mg and 3 mg once-daily in participants with moderate to severe CD to support the selection of an induction and maintenance dose(s) for Phase 3.

Study A consists of a 14-week induction and a 52-week extension period. The primary outcome measures is number and severity of adverse events.

Key secondary measures include efficacy as measured by the Simple Endoscopic Score in CD (SES-CD) and the Crohn's Disease Activity Index.

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

Etrasimod is intended to provide 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, eosinophilic esophagitis, atopic dermatitis, and alopecia areata.

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


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