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IMCY-0098 is a synthetic peptide immunotherapy developed by ImCyse for the treatment of type 1 diabetes mellitus. It belongs to a new class of active and specific immunotherapies called Imotopes™, designed to halt or delay disease progression by eliminating pathogenic immune cells involved in the autoimmune destruction of pancreatic beta cells. The drug is derived from human proinsulin and contains a thiol-disulfide oxidoreductase motif at the N-terminus. Its mechanism involves stimulating cytolytic CD4+ T cells that specifically target and eliminate autoreactive T cells, thereby protecting pancreatic beta cell function. Clinical studies have shown that IMCY-0098 induces an insulin-specific cytolytic CD4+ immune signature and prevents expansion of insulin-specific pathogenic Th17 T-cells. The drug has demonstrated a favorable safety profile in phase 1b trials but did not show efficacy in primary analysis during phase II trials, leading to termination of further development for type 1 diabetes[2][4][5][6][10].
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