17 May Ulcerative Colitis: Lilly Reports Clinically Meaningful Response with Mirikizumab in Phase Two Study
MedicalResearch.com Interview with:
Marla Dubinsky, M.D.
Professor of Pediatrics and Medicine
Co-director of the Susan and Leonard Feinstein IBD Clinical Center
Chief of the Division of Pediatric Gastroenterology and Nutrition
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study? How does MIRIKIZUMAB differ from other medications for UC?
Response: This is a phase 2 study to assess the PK (pharamcokinetics), safety and efficacy of mirikizumab in pediatric ulcerative colitis (UC).
Mirikizumab is a humanized monoclonal antibody that specifically binds to the p19 subunit of interleukin-23, a key inflammatory mediator in inflammatory bowel disease.
MedicalResearch.com: What are the main findings?
Response: In this Phase 2 pediatric UC study, mirikizumab demonstrated similar observed PK concentrations as those reported in adult patients from the LUCENT-1 induction study, and clinically meaningful improvement in clinical response, clinical remission, and endoscopic remission, following induction treatment with mirikizumab. No new safety signals were identified in the pediatric population.
MedicalResearch.com: What should readers take away from your report?
Response: These results provide the first reported efficacy of mirikizumab in pediatric patients with UC and lay the foundation for the pivotal Phase 3 SHINE-2 pediatric study
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
Response: We look forward to the phase 3 study to evaluate the safety and efficacy in a larger UC study population.
Steering committee and site investigator for the Shine Study
Receive consultant Fees from Eli Lilly
1: PK, Efficacy and Safety of Mirikizumab as Induction Therapy in Pediatric Patients with Moderately to Severely Active Ulcerative Colitis: Results from the Phase 2 SHINE-1 Study (Monday, May 8; 2:15 – 2:30 p.m. Presenting author: Jess L. Kaplan)
Digestive Disease Week 2023 Abstract: 781
2: Efficacy and Safety of Mirikizumab as Induction Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Study. Gastroenterol Hepatol (N Y). 2022 Apr;18(4 Suppl 1):7-8. PMID: 35610995; PMCID: PMC9122067.
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Last Updated on May 17, 2023 by Marie Benz