Introduction
T cell-mediated autoimmune disease, arthritis, diabetes
TYPE 1 DIABETES, ARTHRITIS, TYPE 1 DIABETES, DISEASES, DIABETES
Type 1 diabetes is a T cell-mediated autoimmune disease with progressive destruction of insulin-producing beta cells in the pancreas [Oral tolerance, using the oral route and the gut-associated lymphoid tissue to induce immunoregulatory mechanisms, has been successfully explored in other diseases such as arthritis [Teplizumab, an Fc receptor non-binding humanised anti-CD3 antibody, demonstrated therapeutic efficacy in multiple clinical trials in recent-onset and stage 2 diabetes [These preclinical and clinical data have been the basis of a first-in-human (FIH) Phase 1b/2a study with AG019, administered as monotherapy and in combination with teplizumab, in adults and adolescents with recent-onset type 1 diabetes and residual beta cell function. The main study objective was to assess the safety and tolerability of AG019. Secondary endpoints included pharmacokinetic (PK) data to examine AG019 exposure, metabolic data to examine functional beta cell preservation and glycaemic control, and immunological data to gain insight into the mode of action of AG019 in type 1 diabetes.