Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company in the U.S., has published the results of the VIVID-1 study, demonstrating the efficacy of mirikizumab in patients with moderately to severely active Crohn’s disease. The study showed that mirikizumab achieved nominally statistically significant improvements across all histological and histological endoscopic endpoints at weeks 12 and 52 compared to placebo, and versus ustekinumab on several endpoints. Notably, a higher number of patients treated with mirikizumab achieved a histologic response at Week 52 in the overall population, with 58.2% versus 48.8% for the placebo (p=0.0075). In patients with active histologic disease at baseline and with at least one prior biologic failure, mirikizumab also demonstrated greater histologic response at Week 52 (56.5% versus 41.3%; p=0.0064) and endoscopic-histologic response at Week 52 (39.6% versus 27.8%; p=0.024).
Mirikizumab, an IL-23p19 antagonist, selectively binds to the p19 subunit of IL-23, inhibiting its interaction with the IL-23 receptor. The overactivation of the IL-23 pathway is a significant driver of inflammation in Crohn’s disease, a chronic condition characterized by progressive bowel damage, disability, and reduced health-related quality of life. The drug received its first marketing approval in Japan in March 2023 for moderate to severe active ulcerative colitis (UC), with a U.S. market nod following in October. A marketing authorization application for mirikizumab in Crohn’s disease was submitted in China earlier last week, indicating the drug’s potential to expand its reach in treating inflammatory bowel diseases.- Flcube.com
