Patients taking mirikizumab for their moderately to severely active ulcerative colitis (UC), were in symptomatic remission for up to two years as demonstrated in new results from Eli Lilly and Company's Phase 2 study. Symptomatic remission is defined as no more than two bowel movements more than an individual's normal bowel frequency, and no blood in their stool. In a separate, post-hoc analysis of patients treated with mirikizumab in this Phase 2 study, an absence of bowel urgency (the sudden or immediate need for a bowel movement) in patients with moderately to severely active UC at 12 weeks was strongly associated with reduced levels of inflammatory biomarkers, an indicator of disease activity. Both analyses will be presented virtually at United European Gastroenterology Week (UEG Week), taking place October 3-5, 2021. Three Out of Four Patients Continuing Treatment with Mirikizumab Maintained Symptomatic Remission At Two Years: Long-term use of mirikizumab was assessed in a post-hoc analysis. In the one-year maintenance period, 92.5% of patients (n=86) stayed on treatment, and 83.9% of patients (n=78) continued treatment through two years. Among patients who were on mirikizumab for two years, 85.9% achieved rectal bleeding remission (as measured by a rectal bleeding subscore of 0), 84.6% achieved stool frequency remission (as measured by a stool frequency subscore of 0 or 1), and 75.6% of patients were in symptomatic remission. Similar results were seen in this patient population between 52 weeks and 104 weeks. Among patients treated with mirikizumab, results in symptomatic remission, rectal bleeding remission and stool frequency remission were comparable between biologic-naïve patients and those who had prior experience with biologics. The safety profile of mirikizumab was consistent with previously published data, and no new safety signals were observed. Post-Hoc Analysis Showed Relationship Between Patient-Reported Bowel Urgency and Inflammatory Biomarkers in UC: Patients who responded to mirikizumab at week 12 and reported no bowel urgency had significantly greater reductions from baseline measures in two inflammatory biomarkers, C-reactive protein (CRP) found in the blood and fecal calprotectin (fCLP) found in the stool, compared to patients who reported bowel urgency. Absence of bowel urgency was defined as no bowel urgency reported for three consecutive days prior to each scheduled visit, regardless of bowel urgency status at baseline. Levels of CRP and fCLP continued to decrease from 12 weeks to one year for both patient groups. Mirikizumab is currently being studied in Phase 3 trials for UC and Crohn's disease. Efficacy and Safety of Mirikizumab in Patients with Ulcerative Colitis: 104-Week Results from a Phase 2 Randomized Controlled Trial: 186 patients with moderately to severely active UC received treatment with mirikizumab. Patients who responded to mirikizumab after the 12-week induction period (n=93), were re-randomized 1:1 into a double-blind maintenance period to receive mirikizumab 200 mg via IV every 4 weeks (n=47) or every 12 weeks (n=46). Clinical response was defined as: a decrease in 9-point Mayo subscore [rectal bleeding, stool frequency and endoscopy] inclusive of =2 points and =35% from baseline with either a decrease of rectal bleeding subscore of =1 or a rectal bleeding subscore of 0 or 1. Patient-reported efficacy outcomes including symptomatic remission (stool frequency subscore=0 or 1 and rectal bleeding subscore=0), stool frequency remission (stool frequency=0 or 1) and rectal bleeding remission (rectal bleeding=0) were evaluated through 104 weeks. Patients who completed 52 weeks of treatment without loss of response either continued participation in the maintenance period to 104 weeks or rolled over to a long-term extension study and received mirikizumab open-label 200 mg every four weeks. 92.5% (86/93) continued taking mirikizumab throughout the one-year maintenance period, and 83.9% of patients (78/93) continued treatment through two years. At one year, 82.1% (64/78) of patients treated with mirikizumab achieved rectal bleeding remission (as measured by a rectal bleeding subscore of 0 or 1) and 84.6% (70/78) achieved stool frequency remission. At two years, 85.9% (67/78) of patients achieved rectal bleeding remission and 84.6% (66/78) of patients achieved stool frequency remission. At two years, 75.6% (59/78) of patients treated with mirikizumab were in symptomatic remission. Biomarkers and Bowel Urgency in Response to Mirikizumab for Ulcerative Colitis: In this analysis, 249 patients who had achieved a clinical response on 3 different doses of mirikizumab from 0-12 weeks, were re-randomized 1:1 to double-blind maintenance treatment with mirikizumab 200 mg every 4 or 12 weeks and treated through 52 weeks to assess the relationship between patient-reported bowel urgency and inflammatory biomarkers. C-reactive protein (CRP), which is found in the blood, was reduced by a median of 7 milligram per liter of blood [mg/L] from baseline in patients without bowel urgency compared to a 3 mg/L reduction from baseline in patients with bowel urgency (p=0.025). Fecal calprotectin (fCLP), which is found in the stool, was reduced by a median of 1,614 mg/kg from baseline in patients without bowel urgency compared to a 109 mg/kg reduction from baseline in patients with bowel urgency (p=0.003). The association between bowel urgency and inflammatory biomarkers at 12 weeks and 52 weeks was analyzed by pooling treatment arms in the induction and maintenance periods, respectively. The analysis found biomarkers may correlate with bowel urgency. More analyses and larger studies are needed to fully understand the connection between biomarkers and bowel urgency.