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 (NYSE: LLY) Phase 2 study.
| INDIANAPOLIS, Oct. 1, 2021 /PRNewswire/ -- 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 (NYSE: LLY) 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. “Millions of people around the world are living with ulcerative colitis, a chronic inflammatory bowel disease that affects the lining of the colon and causes abdominal pain, bowel urgency and frequency, and bloody stools. These symptoms can be unpredictable and severely disrupt a person’s daily life, even making it hard for them to leave their home, go to work or see family and friends. We need therapies that provide long-term symptom control in order to give patients their lives back,” said Remo Panaccione, M.D., University of Calgary, Inflammatory Bowel Disease Center, and lead author of this analysis. “These exciting Phase 2 results reinforce the potential for mirikizumab to provide that long-term, symptomatic remission from some of the most common and distressing symptoms of ulcerative colitis, specifically stool frequency and rectal bleeding.” 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. For methodology, see the “About the Analyses” section below. 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. For methodology and additional results, see the “About the Analyses” section below. “Results from this analysis suggest that among patients with ulcerative colitis treated with mirikizumab, the absence of bowel urgency may be associated with reduced levels of inflammatory biomarkers, which are important indicators of disease severity,” said Lotus Mallbris, M.D., Ph.D., vice president of immunology development and U.S. and global medical affairs at Lilly. “Taken together, we are excited to share at UEG Week a range of data that showed mirikizumab, if approved, may potentially be the first anti-IL-23p19 therapy that reduces disease activity and offers remission from the debilitating symptoms of stool frequency and rectal bleeding for patients with moderately to severely active ulcerative colitis.” Mirikizumab is currently being studied in Phase 3 trials for UC and Crohn’s disease. About The Analyses
About Mirikizumab About Ulcerative Colitis About Eli Lilly and Company P-LLY Lilly Forward-Looking Statement This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about mirikizumab as a potential treatment for patients with ulcerative colitis and/or Crohn’s disease and reflects Lilly’s current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that mirikizumab will prove to be a safe and effective treatment or that mirikizumab will receive regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
SOURCE Eli Lilly and Company | ||||||
Company Codes: NYSE:LLY |
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