Eli Lilly has shared positive two-year results from an open-label extension (OLE) study of Omvoh (mirikizumab-mrkz) in active Crohn’s disease patients.
The VIVID-2 trial has been evaluating continuous treatment with Omvoh in adults with moderately to severely active Crohn’s disease who completed the phase 3 VIVID-1 study, which supported the US Food and Drug Administration’s January approval of the drug in this indication.
Crohn’s disease is one of the two main types of inflammatory bowel disease (IBD), which affects almost one in every 100 people in the US. The condition causes symptoms such as persistent diarrhoea and abdominal pain and, if not adequately controlled, can lead to complications that require hospitalisation and surgical intervention.
Lilly’s Omvoh is designed to reduce inflammation within the gastrointestinal tract by targeting the interleukin-23p19 protein and also already holds approvals to treat adults with ulcerative colitis, another of the two main forms of IBD.
Results from VIVID-2, presented at this year’s Crohn’s and Colitis Congress, showed that the majority of Crohn’s disease patients receiving two years of continuous treatment with Omvoh achieved long-term clinical and endoscopic outcomes, including 43.8% of those with previous biologic failure.
Among patients who were in clinical remission at one year in VIVID-1, 92.9% maintained clinical remission at two years, while 78.6% of those who achieved endoscopic remission at one year maintained endoscopic remission at the two-year mark and, of those treated in the OLE, 87.6% maintained endoscopic response.
Additionally, 60.8% of patients who were not in clinical remission at one year in VIVID-1 reached this during the second year of treatment in VIVID-2, and 35.4% of those who did not achieve endoscopic remission gained this in the OLE.
Mark Genovese, senior vice president of Lilly immunology development, 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.”
Omvoh has also been recommended by the European Medicines Agency’s human medicines committee to treat Crohn’s disease. The European Commission, which has already approved the drug for ulcerative colitis, will now consider the Committee for Medicinal Products for Human Use’s recommendation as it makes its decision in this indication.