Phase 3 Trial Meets Co-Primary Endpoints: Lilly's Mirikizumab Nears Regulatory Submission for Crohn’s Disease

▎WuXi

Edited by Kant Content Team

Eli Lilly and Company today announced in the Phase 3 trial VIVID-1 that,Compared with placebo, its investigational monoclonal antibody mirikizumab achieved both co-primary endpoints and all key secondary endpoints, with adult patients suffering from moderate to severe active Crohn's disease experiencing significant clinical remission after treatment.Eli Lilly plans to submit this positive Phase 3 trial data to the U.S. FDA and other global regulatory authorities as the basis for the therapy's application for marketing approval to treat Crohn's disease.

Crohn's disease is a chronic systemic condition characterized by inflammation in the gastrointestinal or digestive tract, leading to persistent diarrhea, abdominal pain, and rectal bleeding during flare-ups. It is a progressive disease that worsens over time. Due to the unpredictable nature of Crohn's disease symptoms, it imposes physical, emotional, and financial burdens on patients.

Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of IL-23, blocking IL-23-mediated inflammatory responses.Mirikizumab is being evaluated in multiple clinical trials for the treatment of immune-mediated diseases, including psoriasis, ulcerative colitis, and Crohn's disease.

In the VIVID-1 trial, all patients who received active drug treatment during the 12-week induction phase continued their original treatment and entered the maintenance phase of the study until Week 52. Placebo group patients who did not achieve a clinical response by Week 12 (non-responders) were switched to blinded mirikizumab treatment.

The study met the co-primary endpoints, namely:

Compared with the placebo group, in the mirikizumab group,Achieve clinical remission at Week 12 (defined as the total score of the Crohn's Disease Activity Index [CDAI])

Compared with the placebo group, in the mirikizumab group,The proportion of patients achieving clinical remission at Week 12 and endoscopic remission at Week 52 (defined as a ≥50% reduction from baseline in the Simple Endoscopic Score for Crohn’s Disease [SES-CD] total score) was statistically higher (38.0% vs. 9.0%, p

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In this double-blind, placebo-controlled and active comparator trial, mirikizumab achieved all individual and composite primary and secondary endpoints at week 52 compared to placebo (p

Among patients receiving mirikizumab, 54.1% achieved clinical remission at week 52, compared to 19.6% of those receiving placebo (p

In addition, for the clinical remission endpoint (CDAI

In the trial, the safety profile of mirikizumab was consistent with its known characteristics, and no new safety risks were observed.