礼来 Omvoh（mirikizumab）III期 SHINE-2 儿童溃疡性结肠炎达主要终点，盘前股价反跌约1%

One in two pediatric ulcerative colitis patients who responded to initial treatment with Omvoh remained in clinical remission after one year in a Phase 3 study, as Eli Lilly and Company (LLY) reported positive results from the SHINE-2 trial evaluating the therapy in children and adolescents.
The company said the Phase 3 SHINE-2 study met its primary endpoint, with 50% of patients who responded to Omvoh induction therapy achieving clinical remission at Week 52. The findings were presented at the 2026 United European Gastroenterology (UEG) Week Congress, marking the first one-year Phase 3 results reported by an IL-23p19 inhibitor in pediatric ulcerative colitis.
Ulcerative colitis is a chronic inflammatory bowel disease that causes inflammation and sores in the lining of the colon, often leading to symptoms such as abdominal pain, diarrhea, rectal bleeding and bowel urgency.
The open-label study enrolled children and adolescents aged 4 to 17 years with moderately to severely active ulcerative colitis. Of the enrolled patients, 81% achieved a clinical response after 12 weeks of induction treatment with Omvoh.
Among the patients aged 6 to 17 who responses at Week 12 and continued into the maintenance phase 50% achieved clinical remission at one year. Lilly also reported that 71.2% achieved symptomatic remission, 53.8% achieved endoscopic improvement, and 44.2% achieved endoscopic remission at Week 52.
In another key measure, 50% of responding patients achieved corticosteroid-free clinical remission without surgery after one year. More than half of the participants enrolled in the study had previously failed biological therapies, and about half entered the trial with severe disease activity.
The company said the safety profile observed in pediatric patient was consistent with that previously reported in adults, with no new safety signals identified through one year of follow-up. The most commonly reported adverse events included upper respiratory track infections, injection-site reactions, ulcerative colitis flare-ups, headache, nasopharyngitis and anemia. Four patients experienced serious adverse events, none of which were considered related to the treatment.
Omvoh is currently approved in adults for moderately to severely active ulcerative colitis and Crohn's disease. Lilly said it intends to submit the pediatric study results to global regulators to support a potential label expansion. If approved, Omvoh would become the first IL-23p19 inhibitor for pediatric ulcerative colitis.
Lilly is also continuing to evaluate mirikizumab in pediatric inflammatory bowel disease through long-term extension studies and an ongoing Phase 3 in pediatric Crohn's disease.
LLY has traded between $793.82 and $1292.65 over the past year. The stock closed Friday's trading (October 16, 2026) at $1257.03, up 0.4%. In pre-market trading the stock is at $1244 down 1.05%.
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October 16, 2026 16:06 ET Monthly consumer price inflation data and retail sales figures were the main news from the U.S. economy this week. In Europe, monthly GDP figures from the U.K. gained attention. External trade data from China was in focus in Asia. Elsewhere, the International Monetary Fund released its latest projections for the global economy.