Eli Lilly reports Phase 3 SHINE‑2 trial shows 81% response and 50% remission in pediatric ulcerative colitis
Eli Lilly announced that its Omvoh (mirikizumab‑mrkz) achieved an 81% clinical‑response rate at Week 12 in the single‑arm SHINE‑2 Phase 3 study of children aged 6‑17 with moderately to severely active ulcerative colitis. Among the Week 12 responders, 50% reached clinical remission and 50% achieved corticosteroid‑free remission at Week 52, meeting the primary endpoint. Secondary outcomes included 71.2% symptomatic remission and 44.2% endoscopic remission. The safety profile remained consistent with adult data, with no new safety signals and four serious adverse events (6.3%) unrelated to treatment. Lilly said it will submit the data to global regulators to seek a pediatric label expansion.
Why it matters
The company expects to file regulatory submissions, which could add a new pediatric indication for Omvoh and expand its market opportunity (the company plans to submit these data to global regulators,). Investors should watch for any label‑expansion approval that could boost future sales.
Key facts
- 181% of patients achieved clinical response at Week 12. prnewswire.com
- 250% of Week 12 responders achieved clinical remission at Week 52, meeting the primary endpoint. prnewswire.com
- 350% of responders achieved corticosteroid‑free clinical remission without surgery at Week 52. prnewswire.com
- 471.2% of responders achieved symptomatic remission at Week 52. prnewswire.com
- 544.2% of responders achieved endoscopic remission at Week 52. prnewswire.com
- 6Four patients (6.3%) experienced a serious adverse event, none considered related to study treatment. prnewswire.com
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.