Eli Lilly has revealed that subjects with moderately to severely active Crohn’s disease have achieved long-term clinical and endoscopic outcomes after two years of continuous treatment with Omvoh (mirikizumab-mrkz) in the open-label extension trial, VIVID-2.
This also includes a 43.8% proportion of those with previous biologic failure.
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Participants in the Phase III VIVID-1 study, who were randomised to receive Omvoh and achieved an endoscopic response after treatment for one year, continued with the maintenance therapy in the VIVID-2 trial.
Findings included the maintenance of clinical remission, as measured by Crohn’s Disease Activity Index (CDAI), in 92.9% of subjects at the two-year mark.
Additionally, 87.6% of the subjects maintained an endoscopic response, indicating visible healing of the intestinal lining.
For those in endoscopic remission at one year of treatment in the Phase III VIVID-1 trial, 78.6% maintained this remission at the two-year mark.
Subjects who had not achieved clinical and endoscopic remission at one year, saw improvements during the second year, with 60.8% reaching clinical remission and 35.4% achieving endoscopic remission.
The therapy’s long-term safety profile remained consistent throughout the study.
Lilly immunology development senior vice-president Mark Genovese said: “These results build on the body of evidence that demonstrates Omvoh’s ability to provide early meaningful improvement and long-term disease control with strong clinical, endoscopic, and histologic outcomes.”
In the initial randomised, placebo-controlled VIVID-1 trial, subjects received the therapy intravenously and then subcutaneously every four weeks.
Last month, the US Food and Drug Administration approved the therapy for treating moderately to severely active Crohn’s disease in adult subjects.
Omvoh targets the interleukin-23p19 (IL-23p19) protein to decrease gastrointestinal inflammation.
Additional trials on the therapy are being conducted by the company, including studies on paediatric subjects, adults with UC, and a Phase IV real-world evidence study.
In November 2024, the company shared outcomes from the Phase III SUMMIT trial of tirzepatide, targeting heart failure with preserved ejection fraction (HFpEF) and obesity.
