Eli Lilly and Company has announced the results from the VIVID-2 open-label extension study, which showed the majority of patients with moderately to severely active Crohn's disease receiving two years of continuous treatment with Omvoh® (mirikizumab-mrkz) achieved long-term clinical and endoscopic outcomes, including those (43.8 percent) with previous biologic failure. 

Data from this study will be presented at the Crohn's and Colitis Congress (CCC), being held from February 6-8, 2025 in San Francisco. 

Omvoh works to reduce inflammation within the gastrointestinal tract by targeting a specific protein, interleukin-23p19 (IL-23p19), which is a key contributor to intestinal inflammation.

"Many people living with Crohn's disease have tried available therapies without success or have experienced a loss of efficacy with their treatment," said Edward Barnes, M.D., MPH, Associate Professor of Medicine in the Division of Gastroenterology and Hepatology, Co-Director of the Multidisciplinary Inflammatory Bowel Diseases Center at the University of North Carolina at Chapel Hill. 

"These positive, multi-year data can give health care providers confidence that Omvoh may help their patients achieve and maintain long-term outcomes, including intestinal healing," added Barnes.

Participants randomised to Omvoh in the Phase 3 VIVID-1 study who achieved endoscopic response after one year of treatment continued Omvoh maintenance treatment in VIVID-2. The following results were achieved based upon observed case analysis after two years of continuous treatment, including one year during VIVID-1:

Among patients who were in clinical remission at one year in VIVID-1, 92.9 percent maintained clinical remission at two years as measured by Crohn's Disease Activity Index (CDAI).

Among patients treated in VIVID-2, 87.6 percent maintained endoscopic response, defined by visible healing of the intestinal lining and measured by a ≥50 percent reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score.

Among patients who were in endoscopic remission at one year of treatment in VIVID-1, 78.6 percent maintained endoscopic remission at two years as measured by SES-CD ≤4 and ≥2-point reduction from baseline, with no subscore >1 in any individual variable.

Additionally, among patients who were not in clinical remission by CDAI at one year, 60.8 percent gained clinical remission during the second year of treatment.

Among patients who were not in endoscopic remission at one year, 35.4 percent gained endoscopic remission during the second year of treatment. These results were also evaluated using a modified non-responder imputation method, presented in the About the VIVID Clinical Trial Program section below.

In VIVID-2, the long-term safety profile of Omvoh in patients with moderately to severely active Crohn's disease was generally consistent with the known safety profile of Omvoh. During the second year of continuous treatment with Omvoh, 6.8 percent of patients with endoscopic response at one year reported a serious adverse event and 0.8 percent discontinued treatment due to an adverse event.

"Lilly is setting a high bar for sustained and durable treatment response for patients living with the profound impact of inflammatory bowel disease," said Mark Genovese, M.D., senior vice president of Lilly Immunology development.

Omvoh was approved by the United States Food and Drug Administration (FDA) for the treatment of moderately to severely active Crohn's disease in adults in January 2025. In December 2024, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Omvoh for the treatment of adults with moderately to severely active Crohn's disease. 

Lilly has submitted marketing applications around the globe, including in Canada, Japan and China, with additional global regulatory submissions planned. Omvoh is also approved in 44 countries for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Omvoh is the first and only IL-23p19 antagonist to demonstrate long-term, multi-year, sustained efficacy and safety for both Crohn's disease and UC.

It has additional ongoing trials in Crohn's disease and UC, including studies to evaluate the long-term efficacy and safety of Omvoh in pediatric patients and adults, and a Phase 4 real-world evidence study to evaluate Omvoh's impact in patients with UC in clinical practice.