Eli Lilly’s mirikizumab shows efficacy in Crohn’s disease

Eli Lilly reported results from its pivotal Phase 3 VIVID-1 study in which patients with moderately to severely active Crohn’s disease, with or without previous biologic failure, achieved statistically significant and clinically meaningful improvements across multiple clinical and endoscopic endpoints at one year with mirikizumab compared to placebo. Data from this study will be presented at Digestive Disease Week in Washington, D.C. from May 18-21. Mirikizumab achieved both co-primary endpoints and all major secondary endpoints at Week 52 compared to placebo, including: proportion of participants achieving clinical response by patient reported outcomes at Week 12 and clinical remission at Week 52 vs. placebo. At one year, clinical remission and endoscopic response were achieved by 54.1% and 48.4% of patients on mirikizumab, respectively. Notably, of the patients who received mirikizumab, 56.7% of bio-naive and 51.2% of bio-failed patients achieved clinical remission 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. The frequency of serious adverse events was greater in placebo than mirikizumab. Lilly submitted a supplemental Biologics License Application for mirikizumab in Crohn’s disease to the FDA and EMA this year. Additional global regulatory submissions are planned.