Lilly's Omvoh (mirikizumab-mrkz) meets primary endpoint of clinical remission and is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis
Lilly announced one-year Phase 3 SHINE-2 results showing Omvoh met its primary endpoint in pediatric ulcerative colitis, with 81% of patients responding to induction and 50% of responders in clinical remission at Week 52. Omvoh is the first IL-23p19 inhibitor to report one-year Phase 3 data in pediatric UC, and Lilly plans regulatory submissions for a potential label expansion into patients ages 6 to 17.
Key figures
- Drug Name
- Omvoh (mirikizumab-mrkz)
- Phase Of Trial
- Phase 3
- Patients enrolled
- 63
- Serious adverse events
- 6.3% (4 patients), none deemed treatment-related
- Clinical remission week52
- 50%
- Endoscopic remission week52
- 44.2%
- Symptomatic remission week52
- 71.2%
- Endoscopic improvement week52
- 53.8%
- Steroid free remission week52
- 50%
- Clinical response induction week12
- 81%
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.