October 12,Eli LillyAnnounce,Mirikizumab vs. PlaceboThe Phase III VIVID-1 study 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 LillyPlan to submit the marketing application for mirikizumab to the FDA in 2024 for the treatment of Crohn's disease.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, the mirikizumab group achieved clinical response at week 12.(By assessing stool frequency and abdominal pain)And achieved clinical remission at Week 52(As assessed by the Crohn's Disease Activity Index [CDAI], defined as a CDAI score <150)A higher proportion of patients (45.4% vs 19.6%, P<0.000001); 2) Compared with the placebo group, the mirikizumab group achieved clinical response at week 12 and endoscopic response at week 52.(As assessed by the Simplified Endoscopic Score for Crohn's Disease [SES-CD], defined as a 50% or greater reduction in the total SES-CD score)The proportion was higher (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 endpoint of endoscopic response in week 52, mirikizumab did not achieve superiority over ustekinumab, although the numerical results for mirikizumab were higher, particularly in the population with prior failure of biologic therapies without multiplicity control.Copyright © 2023 PHARMCUBE. All Rights Reserved.
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