Eli Lilly is betting on a pediatric expansion to give it’s IL-23p19 inhibitor Omvoh an edge in the fiercely competitive inflammatory bowel disease (IBD) market.
The Indianapolis-based drugmaker just announced a positive readout for its Shine-2 phase 3 trial of Omvoh in pediatric patients ages six to 17 years with moderately to severely active ulcerative colitis (UC). Half of the children enrolled in the single-arm study achieved clinical remission by one year, achieving the primary endpoint in what Lilly hailed as the longest pediatric IL-23p19 study to date.
The first-in-class Omvoh is given as a 12-week IV induction regimen and then through monthly subcutaneous maintenance injections. The biologic is already approved to treat IBD in adults, securing an initial UC approval in 2023 and another for Crohn’s disease in 2025.
Lilly said it plans to submit the Shine-2 data, simultaneously presented at United European Gastroenterology Week in Barcelona, to the FDA and other global regulators in pursuit of a pediatric label expansion.
“UC affects more than 25,000 U.S. kids, and the pediatric presentation is often aggressive and severe in nature, more so than the initial adult presentation,” said Mark Genovese, M.D., senior vice president of Lilly immunology development. With that in mind, a 50% remission rate “is absolutely phenomenal ... it’s delivering really high benefit.”
To be included in the study, pediatric patients had to have active UC. Sixty-three participants were enrolled and more than half of the participants had already tried another biologic or advanced therapy and continued to have active disease.
Of the enrolled patients, 81% responded to Omvoh induction treatment within 12 weeks. And of those responders, 73% continued to show a clinical response at one year.
Half of the patients achieved clinical remission after one year. A closer look revealed 50% also achieved corticosteroid-free remission, meaning they received no corticosteroids within the prior 12 weeks, and 44% achieved endoscopic remission showing no evidence of disease in digestive tract after a year on treatment.
Importantly, these were not mild or moderate cases of UC to begin with, Genovese told Fierce: “Fifty percent of these children met the modified Mayo score for severe disease, meaning a score of seven to nine.”
The safety profile was consistent with Lilly’s adult UC data. The most common adverse event was upper respiratory infection.
Despite its first-mover advantage in adult UC and what the company positions as some of the best long-term data in the game, Lilly has faced fierce competition in the adult IBD arena. Powerhouses like Skyrizi, Tremfya and Stelara claim much of the market.
In Lilly’s most recent earnings report, Omvoh brought in $102 million in second-quarter sales, a solid 36% increase over the $75 million it earned in Q2 of 2025. Still, AbbVie reports that Skyrizi, approved in UC in 2024, already snags roughly three-fourths of first-line IL-23 IBD prescriptions.
The pediatric IBD market, though, is significantly smaller and less crowded. No other IL-23p19 inhibitors are approved in the space, where J&J’s Stelara—a dual IL-12/23 inhibitor—secured FDA approvals in pediatric Crohn’s disease and UC in children as young as two earlier this year, marking the first non-TNF drug to do so.
If Omvoh’s bid for pediatric UC is approved, Stelara and its biosimilar would be direct rivals. And while separate clinical trials can’t be directly compared, a look at both pediatric studies doesn’t reveal a clear winner. Stelara’s 52-week clinical remission rate and steroid-free remission rate were lower than Omvoh’s at 40%, but its symptomatic remission rate was higher at 65%. Stelara’s phase 3 also included twice the number of patients.
In adults, Lilly appears to be positioning Omvoh as an option when other biologics have failed. In a post-hoc analysis of the drugmakers' adult IBD programs, Lilly showed that Omvoh achieved multiple treatment goals simultaneously in adult UC and Crohn’s disease over a one-year treatment course—both for newly diagnosed patients and patients with prior biologic failure.
Similarly, “after ustekinumab, there aren’t many therapies available for pediatrics,” Genovese said, referring to Stelara by its generic name. “We’re enthusiastic about the idea we’re doing something for kids.”