Eli Lilly and Company announced new data showing that treatment with Omvoh (mirikizumab-mrkz) led to early and sustained improvements in bowel urgency severity, frequency, and stool deferral time in patients with moderately to severely active ulcerative colitis (UC). Findings from the Phase 3b LUCENT-URGE study will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place October 24–29 in Phoenix, Arizona.

LUCENT-URGE is the first study in inflammatory bowel disease to assess bowel urgency across three dimensions—severity, frequency, and stool deferral time—capturing the full scope of its burden on patients. By Week 12, participants experienced a 55 per cent reduction in daily bowel urgency episodes, and severity decreased by more than half by Week 28. By Week 28, nearly one-third of patients were able to delay using the restroom for at least 15 minutes after feeling the urge—up from just 4 per cent at baseline.

“For many people living with ulcerative colitis, the sudden and unpredictable need to find a restroom can be highly disruptive and stressful, often dictating their daily routines and limiting their social and professional lives,” said David Rubin, M.D., Professor of Medicine and Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine. “These results reinforce earlier findings that Omvoh can help patients regain control over a symptom that has long affected their quality of life.”

Clinical, endoscopic, and histologic improvements were consistent with previously disclosed results from the LUCENT Phase 3 program. The safety profile in patients with moderately to severely active UC was also consistent with the known safety data for Omvoh, with no new safety signals observed. In LUCENT-URGE, 5.2 per cent of patients experienced a serious adverse event, and 4.7 per cent discontinued treatment due to an adverse event.

“Lilly continues to advance innovative science to better understand and treat bowel urgency, recognizing that comprehensive management of ulcerative colitis must address the real-world challenges patients face every day,” said Mark Genovese, M.D., Senior Vice President of Lilly Immunology Development. “With Omvoh, we are fulfilling our commitment to improving meaningful outcomes for patients living with this chronic condition.”

The findings from LUCENT-URGE build on insights from Lilly’s CONFIDE study, which highlighted the often-overlooked daily burden of bowel urgency and related symptoms in people with ulcerative colitis. Lilly also recently presented four-year final data from LUCENT-3, demonstrating long-term improvements in bowel urgency severity.