Eli Lilly Shares Positive Phase III Data of Mirikizumab for the Treatment of Crohn’s Disease

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Eli Lilly has shared results from two Phase III clinical trials which show patients treated with mirikizumab sustained stable, long-term remission across two types of inflammatory bowel diseases (IBD), ulcerative colitis (UC), and Crohn's disease. Data will be presented at this year’s American College of Gastroenterology (ACG) Annual Meeting in Philadelphia, PA.¹

According to Lilly, mirikizumab is the first and only IL23p19 antagonist to achieve multi-year, long-term sustained efficacy for the treatment of both UC and Crohn’s disease. In October 2023, the FDA approved mirikizumab under the brand name Omvoh for the treatment of moderately to severely active UC in adults.

In the LUCENT-3 study, which evaluated mirikizumab in moderately to severely active UC, patients achieved long-term outcomes, including histologic-endoscopic mucosal remission. Additionally, mirikizumab provided sustained benefit across symptomatic, clinical, endoscopic, and histologic endpoints.

Meanwhile, the VIVID-2 long-term extension study, which evaluated the efficacy of mirikizumab in moderately to severely active Crohn's disease, showed patients maintained high rates of clinical and endoscopic remission.

In a press release, Bruce Sands, MD, MS, Dr. Burrill B. Crohn professor of medicine and chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai said, "Despite continued advances, people living with ulcerative colitis and Crohn's disease are still seeking treatments that can address difficult-to-manage symptoms such as bowel urgency, and provide lasting results over time. These multi-year data show mirikizumab is a targeted therapy that can provide intestinal healing over time and improvement in key symptoms that matter most to patients."

Elsewhere in the Crohn’s disease space, Johnson & Johnson shared new Phase III data from its GRAVITI trial of Tremfya (guselkumab). At 12 weeks, 56.1% of patients achieved clinical remission, and at 48 weeks, rates of remission continued with maintenance doses.²

According to J&J, Tremfya is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn’s disease. The inhibitor was approved by the FDA for adults with moderately to severely active UC earlier in September.

“The GRAVITI results show that induction treatment with subcutaneous guselkumab is as rapid and robust as we have seen with the IV induction, which could offer a welcome new option for Crohn’s disease treatment,” study investigator Remo Panaccione, MD, FRCPC, professor of medicine and director of the inflammatory bowel disease unit at the University of Calgary, said in a press release. “The one-year results of this study suggest that SC induction with guselkumab is a promising approach to help people with CD manage their symptoms and achieve meaningful endoscopic improvements.”

References

1. Lilly's mirikizumab is first and only IL23p19 antagonist to report long-term, multi-year, sustained efficacy and safety data for both ulcerative colitis and Crohn's disease. News release. Eli Lilly. October 28, 2024. Accessed October 30, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-mirikizumab-first-and-only-il23p19-antagonist-report-long

2. TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn’s disease. News release. Johnson & Johnson. October 28, 2024. Accessed October 30, 2024. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-is-the-first-and-only-il-23-inhibitor-to-demonstrate-robust-results-with-a-fully-subcutaneous-regimen-in-both-induction-and-maintenance-in-crohns-disease