Eli Lilly and Company said Monday that 50% of Week 12 Omvoh (mirikizumab-mrkz) responders ages 6 to 17 reached clinical remission at Week 52, supporting a planned submission to regulators for pediatric use.
The Phase 3 SHINE-2 trial enrolled 63 participants ages 4 to 17. Its primary remission analysis covered 52 participants ages 6 to 17 who responded after 12 weeks of treatment. Those responders received injections based on their weight every four weeks through Week 52.
Omvoh is approved in the United States for adults with moderately to severely active ulcerative colitis. The U.S. Food and Drug Administration's labeling says its safety and effectiveness in children have not been established.
On a separate outcome measure, 71.2% of the Week 12 responders were in symptomatic remission at Week 52. Half met the measure for clinical remission without corticosteroids or surgery. Lilly said 54% of participants had previously experienced biologic-treatment failure, while half entered the trial with severe disease activity.
SHINE-2 was open-label and had a single treatment arm. Without a pediatric control group, its results cannot show how Omvoh performed against a placebo or another treatment.
Lilly assessed the primary endpoint against placebo remission data from its separate adult LUCENT-2 trial. The lower end of an 80% credible interval for the pediatric result was 42.8%, above the 32.6% upper end of a 90% credible interval for the adult placebo rate. That benchmark does not provide a direct treatment comparison within SHINE-2.
Two of the 63 participants stopped treatment because of an ulcerative colitis flare, a 3.2% discontinuation rate. Lilly recorded serious adverse events in four participants (6.3%) and said none was related to treatment. It reported no deaths, malignancies, opportunistic infections or growth-related safety concerns through Week 52.
Lilly presented the findings Monday at United European Gastroenterology Week in Barcelona. The company plans to submit the SHINE-2 data to regulators worldwide but has not announced a submission date.
