Eli Lilly announces one-year histologic mirikizumab data

Eli Lilly announced data demonstrating more patients with moderately to severely active Crohn’s disease treated with mirikizumab achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. VIVID-1 is the first Phase 3 study for any approved or investigational treatment in Crohn’s disease to report histologic and combined histologic-endoscopic outcomes that were evaluated using a systematic assessment of five bowel segments and strict definitions consistent with the recently published European Crohn’s and Colitis, or ECCO, position statement on mucosal histopathology. These results are being presented as an oral presentation at United European Gastroenterology, or UEG, Week, held in Vienna, Austria from October 12-15. Mirikizumab is an IL23p19 antagonist that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. Inflammation due to the overactivation of the IL-23 pathway plays a critical role in pathogenesis of Crohn’s disease, a chronic, inflammatory bowel disease associated with progressive bowel damage, disability and decreased health-related quality of life. In VIVID-1, mirikizumab achieved nominally statistically significant improvements across all histologic and histologic-endoscopic endpoints versus placebo at Weeks 12 and 52, and versus ustekinumab on the following endpoints. A greater number of patients that achieved histologic response were observed with mirikizumab at Week 52 in the overall population. In patients with active histologic disease at baseline and with at least one prior biologic failure, mirikizumab also showed greater histologic response at Week 52 and endoscopic-histologic response at Week 52. The overall safety profile of mirikizumab in patients with moderately to severely active Crohn’s disease was consistent with the known safety profile in patients with ulcerative colitis, or UC. The frequency of serious adverse events was greater in placebo than mirikizumab. The most common adverse events were COVID-19, anemia, arthralgia, headache, upper respiratory tract infection, nasopharyngitis and injection site reactions. Lilly has submitted marketing authorization applications for mirikizumab in Crohn’s disease around the globe, including in the U.S., Europe, Japan and China. Additional global regulatory submissions are planned. Lilly is committed to finding solutions to elevate care and improve treatment outcomes for people living with inflammatory bowel disease, which includes studying the long-term efficacy and safety of mirikizumab in pediatric patients and adults. Mirikizumab is approved for the treatment of moderately to severely active UC in adults and is marketed as Omvoh. Mirikizumab has additional ongoing trials in UC, including a study in pediatric patients and a study to evaluate the long-term efficacy and safety of mirikizumab in adults. Lilly is continuing to advance the science with an open-label UC trial studying two new endpoints in the assessment of bowel urgency with frequency and deferral time, both of which impact the quality of life for patients.