Omvoh (mirikizumab-mrkz) for Crohn’s disease achieved sustained clinical remission and endoscopic response at two years for most patients – Eli Lilly

Eli Lilly and Company announced 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%) with previous biologic failure. Data from this study has been presented at the Crohn’s and Colitis Congress (CCC) in February, 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 & 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.”

Participants randomized to Omvoh in the Phase III 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:

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

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

iii) Among patients who were in endoscopic remission at one year of treatment in VIVID-1, 78.6% 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:

i) Among patients who were not in clinical remission by CDAI at one year, 60.8% gained clinical remission during the second year of treatment.

ii) Among patients who were not in endoscopic remission at one year, 35.4% 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% of patients with endoscopic response at one year reported a serious adverse event and 0.8% 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. “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.”

About the VIVID Clinical Trial Program
VIVID-1 was a Phase III randomized, double-blind, placebo-controlled 52-week study in adults with moderately to severely active Crohn’s disease. Patients randomized to Omvoh received Omvoh 900mg by intravenous (IV) infusion at Week 0, Week 4 and Week 8 followed by a maintenance dose of 300mg by subcutaneous injection (SC) at Week 12 and then every 4 weeks (Q4W) for 40 weeks. Participants who completed VIVID-1, including the Week 52 endoscopy, were eligible for VIVID-2. In VIVID-2, the primary objective is to evaluate the long-term effect of Omvoh in clinical remission by CDAI and endoscopic response at Week 52 of treatment in VIVID-2 (totaling 104 weeks of continuous treatment). Safety is being assessed from the first dose in VIVID-2. Using a modified non-responder imputation method, among Omvoh endoscopic responders at year one, 81.8% maintained endoscopic response at two years, 86.9% maintained clinical remission at two years, and 72.5% maintained endoscopic remission at two years.

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.