On Monday, Eli Lilly And Co (NYSE:LLY) announced data from a VIVID-1 Phase 3 study that evaluated the safety and efficacy of mirikizumab compared with a placebo and active control (Johnson & Johnson's (NYSE: JNJ) Stelara (ustekinumab)) in adults with moderately to severely active Crohn's disease.
The data showed that more patients achieved histologic response were observed with mirikizumab at Week 52 in the overall population (58.2% versus 48.8%; p=0.0075).
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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 (56.5% versus 41.3%; p=0.0064) and endoscopic-histologic response at Week 52 (39.6% versus 27.8%; p=0.024).
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 (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.
"As the first company to report rigorous histologic and endo-histologic outcomes in Crohn's disease that align with a recent ECCO position statement, Lilly is setting a higher bar for the evaluation of long-term treatment response in inflammatory bowel disease. This includes more ambitious targets of mucosal healing, which we applied to compare mirikizumab's histo-endoscopic effect to ustekinumab," said Mark Genovese, senior vice president of Lilly Immunology development.
Mirikizumab is approved for moderately to severely active ulcerative colitis (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.
Price Action: LLY stock is up 0.17% at $933.68 at last check Monday.
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