Eli Lilly and Company (Lilly) said that mirikizumab has achieved all the co-primary and all major secondary endpoints in the VIVID-1 Phase 3 trial in adults with moderately to severely active Crohn’s disease.
Mirikizumab is an interleukin-23p19 antagonist. It is currently approved for moderately to severely active ulcerative colitis (UC) in Japan, Germany, the UK, and Canada.
The double-blind, treat-through VIVID-1 trial evaluated the safety and efficacy of mirikizumab against placebo. It also included an active control (ustekinumab) arm.
In the mirikizumab arm of the study, 45.4% of patients achieved clinical response at week 12 and clinical remission at week 52 compared to 19.6% in placebo.
According to Lilly, 38% of patients achieved clinical response at week 12 and endoscopic response at week 52 compared to 9% in placebo.
The interleukin-23p19 antagonist achieved all individual and composite major secondary endpoints at week 52 compared to placebo.
Additionally, 54.1% of patients who were administered with mirikizumab achieved clinical remission at week 52 compared to 19.6% of patients who were given placebo.
Furthermore, the overall safety was similar with the known safety profile of the drug.
Lilly immunology development senior vice president Lotus Mallbris said: “I’m excited by these results, which showed more than half of patients on Mirikizumab achieved clinical remission as measured by CDAI at one year.
“Furthermore, mirikizumab demonstrated robust efficacy across subgroups and particularly in patients for whom prior biologic therapy had failed.”
The study’s co-primary endpoints included proportion of individuals reaching clinical response by patient reported outcomes (PRO) at week 12 and clinical remission at week 52 compared to placebo.
It also included proportion of participants meeting clinical response by PRO at week 12 and endoscopic response at week 52 compared to placebo.
Based on these findings, Lilly will submit a marketing application for mirikizumab in Crohn’s disease to the US Food and Drug Administration (FDA), followed by filings with other regulatory authorities around the world in 2024.
