Lilly's IL-23 Inhibitor Mirikizumab Succeeds in Phase III Crohn’s Disease Trial, Aiming for Regulatory Submission in 2024

On October 12, Eli Lilly announced that the Phase III VIVID-1 study of mirikizumab versus placebo for the treatment of moderate to severe active Crohn's disease met the co-primary endpoints and all key secondary endpoints. This double-blind trial also included a positive control group (ustekinumab). Based on these data, Eli Lilly plans to submit a marketing application to the FDA for mirikizumab in the treatment of Crohn's disease in 2024.

Crohn's disease is a form of inflammatory bowel disease (IBD) that can cause systemic inflammation, presenting with abdominal pain, diarrhea, fever, and weight loss, and may lead to intestinal obstruction, fibrosis, and other complications.

Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of IL-23, thereby blocking IL-23-mediated inflammatory responses.

The study met two co-primary endpoints, namely: 1) Compared with the placebo group, a higher proportion of patients in the mirikizumab group achieved clinical response at week 12 (assessed by stool frequency and abdominal pain) and clinical remission at week 52 (assessed by the Crohn's Disease Activity Index [CDAI], defined as CDAI score <150) (45.4% vs 19.6%, P<0.000001); 2) Compared with the placebo group, a higher proportion of patients in the mirikizumab group achieved clinical response at week 12 and endoscopic response at week 52 (assessed by the Simple Endoscopic Score for Crohn’s Disease [SES-CD], defined as a reduction of 50% or more in the total SES-CD score) (38.0% vs 9.0%, p<0.000001).

In this trial, compared with the placebo group, the mirikizumab group achieved all individual and composite primary and secondary endpoints at week 52 (p<0.000001). Notably, 54.1% of patients in the mirikizumab group achieved clinical remission at week 52, compared with 19.6% in the placebo group (p<0.000001).

Moreover, at the endpoint of clinical remission, mirikizumab demonstrated non-inferiority compared to ustekinumab (with a non-inferiority margin of 10%); at the week 52 endoscopic response endpoint, mirikizumab did not achieve superiority over ustekinumab, although the numerical results for mirikizumab were higher, particularly in the biologic-experienced population without multiplicity control.

In April this year, the reason was that the FDA had some questions about the proposed manufacturing process of mirikizumab, but did not express concerns about the drug's clinical data, safety, or labeling.

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