First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes.

ABSTRACT:

Background

Type 1 diabetes (T1D) is a CD4⁺ T cell-driven autoimmune disease characterized by the destruction of insulin-producing pancreatic β-cells by CD8⁺ T cells. Achieving glycemic targets in T1D remains challenging in clinical practice; new treatments aim to halt autoimmunity and prolong β-cell survival. IMCY-0098 is a peptide derived from human proinsulin that contains a thiol-disulfide oxidoreductase motif at the N-terminus and was developed to halt disease progression by promoting the specific elimination of pathogenic T cells.

Methods

This first-in-human, 24-week, double-blind phase 1b study evaluated the safety of three dosages of IMCY-0098 in adults diagnosed with T1D < 6 months before study start. Forty-one participants were randomized to re

SUBMITTER: Van Rampelbergh J 

PROVIDER: S-EPMC10210318 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature