Eli Lilly reports new data from LUCENT-URGE study

New data from Eli Lilly (LLY) showed Omvoh-treated patients with moderately to severely active ulcerative colitis and bowel urgency experienced early improvements in bowel urgency severity, frequency and stool deferral time by Week 12. These outcomes continued to improve through 28 weeks. The Phase 3b single-arm, open-label LUCENT-URGE study was specifically designed to assess bowel urgency and is the first in inflammatory bowel disease to include the novel endpoints of bowel urgency frequency and stool deferral time to more fully capture the patient experience. These results will be presented at the American College of Gastroenterology annual scientific meeting, taking place Oct. 24-29 in Phoenix. Bowel urgency severity was reduced by 52% at Week 28, with the average Urgency Numeric Rating Scale score dropping from 6.9 at baseline to 3.7 at Week 12 and 3.3 at Week 28. Patients reported a 55% reduction from baseline in the number of times they experienced bowel urgency per day, from 6.9 times per day at baseline to 3.1 at Week 12, which was maintained at Week 28. The proportion of patients who were able to delay a bowel movement for at least 15 minutes or experienced no urgency in the previous 24 hours increased from 4.1% at baseline to 15.7% at Week 12 and 29.7% at Week 28, allowing them more time to reach a restroom. Clinical, endoscopic and histologic improvements were consistent with previously disclosed LUCENT Phase 3 trial data. The safety profile in patients with moderately to severely active UC was consistent with the known safety profile of Omvoh with no new safety signals observed. In LUCENT-URGE, 5.2% of patients reported a serious adverse event, while 4.7% discontinued treatment due to an adverse event.