Oral S1P receptor modulator etrasimod shows benefits in severe UC
Arena Pharmaceuticals announced that etrasimod, its novel, oral selective sphingosine 1-phosphate receptor modulator, showed benefits in the treatment of ulcerative colitis in the phase 2 OASIS trial.
“The results of this phase 2 trial are impressive and demonstrate statistically significant efficacy of orally administered etrasimod, including clinically meaningful improvement in remission, as well as endoscopic improvements in what has been historically referred to as mucosal healing,” William Sandborn, MD, professor of medicine and chief of the division of gastroenterology and director at the University of California San Diego Inflammatory Bowel Disease said in a press release. “Despite recent advances in treatment options, there remains a significant unmet need for new oral therapies for ulcerative colitis. I look forward to etrasimod advancing into a phase 3 program.”
Sandborn and colleagues studied etrasimod in a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study that included 156 patients with moderate-to-severe ulcerative colitis.
Patients who received 2 mg of etrasimod experienced a 0.99-point improvement in a 3-component Mayo Clinic Score (stool frequency, rectal bleeding and findings in endoscopy) relative to placebo (P = .009). More patients in the 2 mg etrasimod group also experienced endoscopic improvement compared with the placebo group (41.8% vs. 17.8%; P = .003).
Patients tolerated the drug well and experienced fewer serious adverse events compared with placebo.
“We believe these data support proceeding to a phase 3 program in ulcerative colitis and continuing efforts to understand the broad potential utility of etrasimod in other immune and inflammatory diseases with significant unmet needs,” Preston Klassen, MD, MHS, executive vice president for research and development and chief medical officer of Arena Pharmaceuticals said in the press release.
Arena plans to present the full study results at future medical congresses.
Disclosures: Klassen is employed by Arena, and Sandborn reports he is a consultant for Arena.