Eli Lilly and Company (Lilly) has reported that the Phase III VIVID-1 study of mirikizumab for the treatment of Crohn’s disease has met its co-primary and all major secondary endpoints.
The treat-through, double-blind, placebo and active-controlled study assessed the efficacy and safety of the interleukin-23p19 antagonist mirikizumab in adults with moderately to severely active Crohn’s disease.
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It included mirikizumab, placebo and active control (ustekinumab) arms.
In the study, active treatment arms’ patients from the 12-week induction period continued with their original therapy into the maintenance portion up to week 52.
Patients in placebo arm who did not achieve clinical response at week 12 were switched to receive blinded treatment with mirikizumab.
In the mirikizumab arm, a statistically higher proportion achieved clinical response by patient reported outcomes (PRO) at week 12, clinical remission and endoscopic response at week 52 compared to placebo.
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By GlobalDataMirikizumab also achieved all individual and composite major secondary endpoints, including clinical remission at week 52 compared to placebo.
It also demonstrated non-inferiority against ustekinumab and for the endpoint response at week 52, mirikizumab failed to achieve superiority to ustekinumab.
Overall safety was said to be consistent with the therapy’s known safety profile and the frequency of serious adverse events was observed to be greater in placebo compared to the mirikizumab arm.
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.
“Helping patients achieve long-term clinical remission is what inspires us to develop innovative treatments for inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis.”
Lilly will use the data obtained from this trial to submit a marketing application to the US Food and Drug Administration for mirikizumab in Crohn’s disease and to other regulatory agencies globally next year.
