Medicine company Eli Lilly and Company (NYSE: LLY) reported on Mondy that it has recorded positive one-year Phase 3 results for Omvoh (mirikizumab-mrkz) in children and adolescents with moderately to severely active ulcerative colitis, with the SHINE-2 study meeting its primary endpoint. Of patients aged 6 to 17 who responded to induction treatment at Week 12, 50% achieved clinical remission at Week 52, while 81% of participants initially responded to treatment. Lilly plans to submit the data to global regulators to support a potential paediatric label expansion.

Key secondary outcomes at one year included symptomatic remission in 71.2% of responders, corticosteroid-free clinical remission without surgery in 50%, endoscopic improvement in 53.8% and endoscopic remission in 44.2%. The findings make Omvoh the first IL-23p19 inhibitor to report one-year Phase 3 results in paediatric ulcerative colitis.

The safety profile was consistent with that established in adults, with no new safety signals. Four patients (6.3%) experienced serious adverse events, none considered treatment-related, while two (3.2%) discontinued treatment because of ulcerative colitis flare-ups. No deaths, malignancies, opportunistic infections or growth-related safety concerns were reported through Week 52.

Omvoh is approved for adults with moderately to severely active ulcerative colitis and Crohn's disease in 47 countries. Its safety and effectiveness in children have not been established. If approved for paediatric ulcerative colitis, it would be the first IL-23p19 inhibitor indicated for this population.