Background

T1D, hyperglycemia, autoimmune destruction, autoimmune disease
HYPERGLYCEMIA, TYPE 1 DIABETES, AUTOIMMUNE DISEASE, COMPLICATIONS
Type 1 diabetes (T1D) is a chronic autoimmune disease characterized by a loss of self-tolerance to autoantigens expressed by the insulin-producing β-cells in the pancreas. This leads to β-cell destruction, decline in endogenous insulin secretion, and consequent hyperglycemia [Although a unique cause of T1D has not been identified, evidence suggests that T1D results from the interplay of a multigenic background and non-genetic components [Despite the ongoing advances in T1D management, achieving good glycemic targets and preventing complications remains challenging [General immunosuppression, which is partially effective in preserving β-cells from autoimmune destruction in recent-onset T1D, carries the risk of side effects that preclude its long-term use [Imotopes™ are linear synthetic peptides comprising an MHC/HLA class II-restricted T-cell epitope sequence linked to a thiol-disulfide oxidoreductase motif [IMCY-0098 is the Imotope™ developed for T1D. The design of IMCY-0098 was based on previous literature [Figure to show summary of IMCY-0098 structure and the HLA class II epitopes it will bind based on previous literature [Here, we present the results of a first-in-human phase 1b study of Imotope™ technology platform using IMCY-0098 in patients with recent onset T1D across seven European countries (NCT03272269; EudraCT number 2016–003514-27). Alongside safety as a primary objective, multiple clinical response parameters were also examined to potentially inform future trials.