Etrasimod — an oral, selective sphingosine 1 phosphate receptor modulator — demonstrated durable clinical remission in the treatment of moderate to severely-active ulcerative colitis in a phase 2 open-label extension study, according to a press release issued by the manufacturer, Arena Pharmaceuticals.
“There remains a significant unmet need for new oral therapies for ulcerative colitis,” Bruce E. Sands, MD, of Mount Sinai Hospital and the Icahn School of Medicine, said in the release. “It is encouraging to see longer-term safety and tolerability data and durable treatment effects of etrasimod, which are important for patients suffering from this chronic condition.”
The 34-week open-label extension study explored the long-term safety, tolerability and efficacy of etrasimod in 118 patients who completed the 12-week phase 2 OASIS randomized, controlled trial. Researchers analyzed the data to determine clinical response, clinical remission and endoscopic improvement at the end of 46 weeks of treatment.
Of the patients who completed 2 mg of etrasimod treatment during the extension study (n = 84), 79% achieved clinical response, 39% achieved clinical remission and 51% had endoscopic improvement by the end of the study. Among patients who also received 2 mg of etrasimod during the OASIS trial (n = 22), 82% experience clinical response, 50% were in clinical remission and 55% had endoscopic improvement.
For patients who achieved clinical response or clinical remission after the OASIS trial, 93% experienced sustained response and 75% experienced sustained remission at both 12 and 46 weeks.
Investigators found that adverse events in the extension study were mild to moderate and did not discover any new safety concerns.
Arena Pharmaceuticals plans to present the full study results at upcoming medical congresses.
“These data further support our belief in etrasimod as an important future therapy in inflammatory bowel disease and our strong commitment to improve the lives of patients suffering from these grievous conditions," Preston Klassen, MD, MHS, executive vice president of research and development and chief medical officer of Arena, said in the release.
Disclosures: Healio Gastroenterology and Liver Disease could not confirm Sands’ relevant financial disclosures prior to publication. Klassen is employed by Arena Pharmaceuticals.