Eli Lilly Reports P-III Study (VIVID-1) Results of Mirikizumab for the Treatment of Crohn's Disease
Shots:
- 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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