IMU-856

IMU-856 is an orally available, systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6), a protein serving as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Its mechanism aims to restore the gut wall and barrier function, offering a novel approach for gastrointestinal diseases such as celiac disease, inflammatory bowel disease, Graft-versus-Host Disease, and other disorders associated with impaired intestinal barrier function. Unlike immunosuppressive therapies, IMU-856 does not suppress immune cells in preclinical studies and may maintain immune surveillance during therapy. In clinical trials for celiac disease, it demonstrated improvements in histology (gut architecture), symptoms, biomarkers, nutrient absorption (e.g., vitamin B12 uptake), and was well tolerated without dose-limiting toxicities or significant adverse events. Additionally, post hoc analyses showed a dose-dependent increase in endogenous glucagon-like peptide-1 (GLP-1) levels and reduced body weight gain/food consumption in preclinical models—suggesting potential utility for weight management[1][2][3][8].