Eli Lilly and Company's Omvoh meets pediatric ulcerative colitis remission endpoint
Half of induction responders were in remission at one year in the uncontrolled Phase 3 study; Lilly plans global regulatory submissions.
Adrian Kessler
Clinical remission reached 50 per cent among induction responders as Eli Lilly and Company NYSELLY said on Monday that Omvoh met its one-year primary endpoint in a Phase 3 pediatric ulcerative colitis study.
The release describes a single-arm, open-label study enrolling 63 participants ages 4 to 17. The reported one-year efficacy analysis covered induction responders ages 6 to 17. Lilly plans global regulatory submissions for a pediatric label expansion, but the announcement gives no filing date.
Lilly is a large Indianapolis drugmaker selling medicines worldwide, with Omvoh among the treatments in its immunology portfolio.
Lilly shares NYSELLY closed at US$1,257.03 in New York on Oct. 16, according to Google Finance's 4:00 p.m. EDT snapshot, before Monday's announcement. Omvoh is already approved for adults with moderately to severely active ulcerative colitis and Crohn's disease.
Remission Was Measured Among Responders
In SHINE-2, 81 per cent of participants achieved clinical response at Week 12. The one-year remission percentage applies to those initial responders rather than everyone enrolled, a distinction that limits how the headline result can be interpreted.
Among responders, 71.2 per cent achieved symptomatic remission and 53.8 per cent had endoscopic improvement at Week 52. Half achieved corticosteroid-free clinical remission without surgery, supporting Lilly's effort to develop a treatment option for children whose disease remains difficult to control.
The study included patients with substantial prior treatment exposure: 54 per cent had experienced biologic treatment failure. Half entered with severe disease activity on the Pediatric Ulcerative Colitis Activity Index, according to Lilly.
The single-arm design supplies no concurrent placebo or active-comparator remission rate. Lilly also cautioned that its descriptive comparison with the adult LUCENT-2 trial should not be interpreted as a direct comparison between studies.
Lilly said four participants experienced serious adverse events, none considered related to treatment, while two discontinued because of ulcerative colitis flare; the company reported no new safety signals through one year. Most treatment-emergent adverse events were mild to moderate.
"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," Mark Genovese, Lilly's senior vice-president of immunology development, said in the release.
The pediatric use remains investigational, so the readout supports a submission plan rather than an authorization to treat children. Lilly is also studying mirikizumab, Omvoh's active ingredient, in pediatric Crohn's disease and a long-term pediatric inflammatory bowel disease extension study.
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Rival Programmes Extend Beyond Remission Rates
Johnson & Johnson NYSEJNJ announced FDA approval on Sept. 19, 2025, for a fully subcutaneous Tremfya induction regimen in adults with ulcerative colitis. That approval gave patients a choice between injections and intravenous induction, illustrating competition over treatment delivery as well as disease control.
AbbVie Inc. NYSEABBV reported on Oct. 11 that its Skyrizi ulcerative colitis extension programme showed sustained clinical and endoscopic improvements through three years. Those findings concerned a separate study and do not establish a comparison with SHINE-2.
For Lilly, a pediatric indication would extend an existing commercial franchise into another patient population. Its Aug. 5 financial results identified Omvoh among its key products and reported second-quarter company revenue of US$23 billion, alongside research and development spending of US$3.8 billion.
Lilly's next scheduled financial update is its third-quarter results on Oct. 29, with a conference call at 10:00 a.m. EDT. That report will update the commercial business's performance; the pediatric programme still needs a dated submission timetable.
