Eli Lilly's mirikizumab promising in Phase 3 Crohn's study

Eli Lilly recently revealed the one-year histologic outcomes from its phase 3 trial of mirikizumab, an interleukin-23p19 antagonist, for treating Crohn’s disease. This late-stage trial, named VIVID-1, assessed the safety and effectiveness of mirikizumab against a placebo and Johnson & Johnson’s Stelara (ustekinumab) in adults suffering from moderately to severely active Crohn’s disease, regardless of their history with biologic treatments.

Crohn’s disease is one of the principal types of inflammatory bowel disease (IBD), affecting nearly one in every 100 individuals in the United States. The condition manifests through symptoms like chronic diarrhea and abdominal pain, which, if not controlled properly, could lead to severe complications necessitating hospitalization or surgery. Mirikizumab, branded as Omvoh, is already approved for treating moderate to severe ulcerative colitis, another major form of IBD in adults.

The findings from the VIVID-1 trial, presented at the recent United European Gastroenterology Week, highlighted that 58.2% of patients treated with mirikizumab displayed a histologic response at week 52, compared to 48.8% of those treated with Stelara. Particularly noteworthy was mirikizumab’s performance in patients with active histologic disease at the beginning of the study and those who had experienced at least one prior biologic failure, with a response rate of 56.5% versus 41.3%. Additionally, 39.6% of these patients achieved an endoscopic-histologic response by week 52, compared to 27.8% of those on Stelara.

Moreover, mirikizumab demonstrated significant improvements in both histologic and histologic-endoscopic endpoints at weeks 12 and 52 when compared to the placebo. These results were considered nominally statistically significant.

Mark Genovese, Senior Vice President of Lilly Immunology development, emphasized that Lilly is pioneering in reporting stringent histologic and endo-histologic outcomes in Crohn’s disease. These outcomes align with the recently published European Crohn’s and Colitis position statement on mucosal histopathology. Genovese noted that the data enhances the understanding of the inflammation driving Crohn’s disease, potentially aiding healthcare providers and patients in making more informed treatment decisions.

Lilly has already submitted applications for marketing authorizations for mirikizumab in treating Crohn’s disease globally, including in the United States and Europe.