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First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes: an exploratory analysis of immune biomarkers

2024; BioMed Central; Volume: 22; Issue: 1 Linguagem: Inglês

10.1186/s12916-024-03476-y

1741-7015

Jean Van Rampelbergh, Peter Achenbach, Richard David Leslie, Martin Kindermans, Frédéric Parmentier, Vincent Carlier, Nicolas Bovy, Luc VanderElst, Marcelle Van Mechelen, Pierre Vandepapelière, Christian Boîtard,

Immune Cell Function and Interaction

IMCY-0098, a synthetic peptide developed to halt disease progression via elimination of key immune cells in the autoimmune cascade, has shown a promising safety profile for the treatment of type 1 diabetes (T1D) in a recent phase 1b trial. This exploratory analysis of data from that trial aimed to identify the patient biomarkers at baseline associated with a positive response to treatment and examined the associations between immune response parameters and clinical efficacy endpoints (as surrogates for mechanism of action endpoints) using an artificial intelligence-based approach of unsupervised explainable machine learning.