The P-III study evaluating mirikizumab (interleukin-23p19 antagonist) vs PBO in 1153 adults with moderately to severely active CD. The trial met the co-1EP i.e., patients achieved clinical response at 12wk. & clinical remission at 52wk. (45.4% vs 19.6%) & patients achieved clinical response at 12wk. and endoscopic response at 52wk. (38.0% vs 9.0%)
The trial also met key 2EPs i.e., at 52wks., 54.1% vs 19.6% achieved clinical remission, mirikizumab was found to be non-inferior for the EPs of clinical remission & was not found to be superior to ustekinumab for the endpoint of endoscopic response
The overall safety was consistent with the known safety profile of mirikizumab. The company plans to submit a marketing application for mirikizumab to the US FDA in CD in 2024
Ref: PR Newswire | Image: Eli Lilly
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