Eli Lilly’s Omvoh Shows 1-Year Phase 3 Results for Kids with Ulcerative Colitis

Eli Lilly and Company (NYSE:LLY) today announced positive late-breaking one-year results from the Phase 3 SHINE-2 study of Omvoh (mirikizumab-mrkz) in pediatric patients ages 6 to 17 with moderately to severely active ulcerative colitis (UC), including clinical, symptomatic and endoscopic outcomes. In the single-arm, open-label study, 81% of patients achieved clinical response to Omvoh induction at Week 12. Among responders, 50% achieved clinical remission at Week 52, meeting the study's primary endpoint.* Omvoh is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric UC. These results were presented as a late-breaking oral presentation at United European Gastroenterology (UEG) Week 2026.1 Omvoh is currently approved for adults with moderately to severely active UC. The safety and effectiveness of Omvoh in pediatric patients are currently being evaluated in clinical studies. Lilly plans to submit these data to global regulators to support a potential label expansion. If approved, Omvoh would be the first IL-23p19 inhibitor indicated for pediatric UC."For children and adolescents, the persistent bowel urgency, abdominal pain and unpredictability of ulcerative colitis can make a normal childhood feel out of reach, especially when symptoms return after previous treatments," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "Already approved for adults with ulcerative colitis, Omvoh is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis. We look forward to working with regulators to potentially make Omvoh available to children and adolescents living with this disease, who continue to face substantial disease burden and ongoing unmet needs."Unmet need in pediatric ulcerative colitisUC affects more than 26,000 children and adolescents in the U.S.3 Although relatively uncommon, pediatric-onset UC is often more extensive and severe than disease that begins in adulthood.4 Up to half of children treated with corticosteroids become dependent on them, and up to one-third require surgery within a year.4SHINE-2 evaluated Omvoh in a pediatric population with high disease burden and significant unmet need, including 54% of enrolled patients who had previously experienced biologic treatment failure. Half entered the study with severe disease activity as measured by the Pediatric Ulcerative Colitis Activity Index.1"For children with ulcerative colitis, every year spent relying on corticosteroids or facing the possibility of surgery can have important implications for growth, development and quality of life," said Marla C. Dubinsky, M.D., Professor of Pediatrics and Medicine at the Icahn School of Medicine at Mount Sinai, Chief of Pediatric Gastroenterology and Nutrition at Mount Sinai Kravis Children's Hospital. "Considering these challenges, the finding that half of the pediatric patients who responded to Omvoh achieved corticosteroid-free clinical remission without surgery at one year is particularly meaningful, especially in a population where many patients had previously experienced treatment failure with advanced therapies."One-year results from SHINE-2 in children and adolescents with ulcerative colitisOf the patients enrolled in SHINE-2, 81% achieved clinical response at Week 12. Among responders, ages 6 to 17, efficacy was sustained across multiple clinical, symptomatic and endoscopic outcomes at Week 52, including:50% clinical remission (primary endpoint)*50% corticosteroid-free clinical remission without surgery† 73.1% clinical response‡ 71.2% symptomatic remission¶ 53.8% endoscopic improvement# 44.2% endoscopic remission**The pediatric Week 52 clinical remission rate was similar to that observed among adult Week 12 responders treated with Omvoh in LUCENT-2 (50.7%).1 This descriptive observation was separate from the primary endpoint analysis and should not be interpreted as a direct comparison between studies.These one-year findings build on the early clinical, symptomatic and endoscopic improvements observed at Week 12, which were presented as a late-breaking oral presentation at the American College of Gastroenterology 2026 Annual Scientific Meeting.5Safety findings from SHINE-2Through Week 52 in SHINE-2, the safety profile of Omvoh in children and adolescents was consistent with its established safety profile in adults, with no new safety signals identified. The most common treatment-emergent adverse events in SHINE-2 were upper respiratory tract infection, injection site reaction, UC, headache, nasopharyngitis and anemia. Most treatment-emergent adverse events were mild to moderate in severity. Through Week 52, four patients (6.3%) experienced a serious adverse event; none was considered related to study treatment. Two patients (3.2%) discontinued treatment because of UC flare. No deaths, malignancies, opportunistic infections or growth-related safety concerns were reported through Week 52.1Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 47 countries around the world. In UC, Omvoh is also approved as a single-injection maintenance regimen in several countries around the world including the U.S., EU, Canada and Japan.Lilly continues to study mirikizumab in pediatric inflammatory bowel disease, including a long-term extension study in UC and Crohn's disease (NCT04844606) and an ongoing Phase 3 study in pediatric Crohn's disease (NCT05509777). Lilly is also evaluating mirikizumab through combination approaches and novel mechanisms aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies in UC with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with zotemtegrast (NCT07186101), an oral α4β7 integrin inhibitor. In Crohn's disease, Lilly is studying mirikizumab in combination with an FXR agonist (NCT07483099). The COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials are investigating the concomitant use of mirikizumab and an incretin-based therapy in adults with UC or Crohn's disease and obesity or overweight with at least one additional weight-related comorbid condition.Disclosure: Dr. Dubinsky is a paid consultant for Lilly. She has not been compensated for any media work.About SHINE-2SHINE-2 is a Phase 3, multicenter, single-arm, open-label study evaluating mirikizumab in pediatric patients with moderately to severely active UC. A total of 63 participants, ages 4 to 17, were enrolled and received weight-based intravenous induction every four weeks for three doses (300 mg for patients >40 kg; 5 mg/kg for patients ≤40 kg). At Week 12, 52 patients entered the maintenance period as clinical responders and received weight-based subcutaneous mirikizumab every four weeks through Week 52. The primary endpoint was evaluated against a pre-specified benchmark derived from the adult placebo remission rate in the Phase 3 LUCENT-2 study.* The Week 52 efficacy results are reported for the Week 12 responder population (N=52; ages 6 to 17); safety results are based on all enrolled patients (N=63).Patients completing SHINE-2 may be eligible to continue in SHINE-ON, an ongoing long-term extension study evaluating mirikizumab in pediatric patients with UC or Crohn's disease.