First-in-Class, interim phase II data in pediatric patients and new analysis from phase III program in adult patients for mirikizumab in ulcerative colitis.-Eli Lilly

Data presented at Digestive Disease Week (DDW), held in Chicago from May 6-9, include an oral presentation of an interim analysis of mirikizumab as induction therapy in pediatric patients with moderately to severely active UC from the Phase II SHINE-1 study, and a new analysis from LUCENT-1 and LUCENT-2 studies evaluating the relative association of bowel urgency remission on Inflammatory Bowel Disease Questionnaire (IBDQ) scores, which assess the impact of UC on quality of life in adults.

Interim Phase II Data from the First IL-23p19 Study in Pediatric Patients with UC : Lilly reported the first pharmacokinetic (PK), efficacy and safety data in 26 pediatric patients with moderately to severely active UC treated with mirikizumab. These interim results are from the Phase II SHINE-1 study (NCT04004611) and include data on all patients through induction at Week 12. The PK, safety and efficacy data were consistent with the adult Phase III LUCENT-1 study and support the planned pediatric Phase III studies in UC and Crohn's disease starting later this year. Importantly, this is the first data of any IL-23p19 antagonist in pediatric patients.

"Ulcerative colitis is a difficult-to-treat disease that can be particularly challenging for children and adolescents given the unpredictable and often burdensome symptoms that can impact them at a critical time in their development," said 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 at the Icahn School of Medicine at Mount Sinai. "This study provides the first data showing the potential of mirikizumab in the treatment of pediatric patients with UC and aligns with the clinical evidence we have seen for mirikizumab in adults. This is a promising step for children, adolescents and their families who to date have had limited treatment options to address this significant unmet need."

New Analysis from the Phase III LUCENT-1 and LUCENT-2 Studies in Adults with UC : In this new analysis, remission of key symptoms of UC, including bowel urgency, was associated with significant improvement in IBDQ total scores among adults treated with mirikizumab. Of those treated with mirikizumab at 12 and 52 weeks, bowel urgency remission directly accounted for a 44.8% and 32.5% improvement in IBDQ total score, respectively; 22.7% and 39.1% improvement, respectively, was mediated by rectal bleeding remission, and 32.5% and 28.4%, respectively, mediated by stool frequency remission.

These findings suggest that bowel urgency is a critical and independent symptom that considerably impacts a patient's quality of life. More information can be found on this study in the abstract linked here.

Lilly will present a total of 11 abstracts at DDW, including four oral presentations, that reinforce its commitment to continued innovation for millions of people living with IBD. The studies, along with the times and abstract numbers for the sessions, are highlighted below.