Lilly announces positive phase 3 results of mirikizumab for UC
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Eli Lilly and Co. announced positive top-line phase 3 results of mirikizumab for moderate to severe ulcerative colitis.
According to a press release, mirikizumab at 1 year in the LUCENT-2 trial met its primary endpoint of clinical remission. In addition, it met its secondary endpoints.
Patients were previously enrolled in LUCENT-1, a 12-week induction study, and were enrolled in the LUCENT-2 trial. They were randomly assigned to maintenance dosing. A statistically higher proportion of patients randomly assigned to mirikizumab compared with placebo met primary endpoint of clinical remission. In addition, other endpoints were met, including achieving endoscopic remission, corticosteroid-free remission, resolution or near-resolution of bowel urgency, improvement in endoscopic histologic intestinal inflammation and maintenance of remission, and greater reduction from baseline in bowel urgency symptoms at 1 year compared with placebo.
"In this maintenance study, treatment with mirikizumab demonstrated clinically meaningful and statistically significant improvements in clinical, endoscopic and histologic measures, including reduction of bowel urgency — a novel endpoint in the LUCENT program," Bruce E. Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine, chief of the Dr. Henry D. Janowitz division of gastroenterology at the Icahn School of Medicine at Mount Sinai, said in the release. "Bowel urgency is one of the most bothersome and disruptive symptoms people living with ulcerative colitis experience, and the LUCENT program leveraged an innovative and systematic patient-centric approach to assess patients' symptoms."
According to the release, in the first half of 2022, Lily anticipated submitting a biologics license application to the FDA for mirikizumab in UC.
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Mirikizumab demonstrates superiority over placebo in phase 3 maintenance study in ulcerative colitis, supporting regulatory submissions in 2022. https://investor.lilly.com/news-releases/news-release-details/mirikizumab-demonstrates-superiority-over-placebo-phase-3 Published Dec. 14, 2021. Accessed Dec. 17, 2021.
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