Century Therapeutics presents diabetes therapy data at EASD

PHILADELPHIA - Century Therapeutics Inc. showcased promising data for its CNTY-813 therapy, an induced pluripotent stem cell-derived islet replacement treatment for type 1 diabetes, at the European Association for the Study of Diabetes' 62nd Annual Meeting in Milan, Italy. The nonclinical research demonstrated that CNTY-813 could maintain glycemic control in diabetic mice for over a year, even after the graft was removed.

All mice treated with CNTY-813 achieved normal blood sugar levels and displayed glucose-stimulated insulin secretion comparable to primary islets. The company's manufacturing process, conducted in compliance with Good Manufacturing Practice standards, produced five batches of the drug with consistent results. In rats, CNTY-813 islets successfully integrated into the liver via the portal vein, mimicking the clinical administration route.

Post-transplant tests revealed the presence of chromogranin A and insulin in the islets, indicating the preservation of their endocrine and beta cell characteristics. The clinical-grade product remained effective after 96 hours of cold storage, and mice receiving these islets experienced normalized blood glucose levels within 30 days and maintained this control for three months post-procedure.

Century Therapeutics has already reached general agreement with the FDA regarding its nonclinical package, Phase 1 manufacturing process, and the proposed Phase 1/2 trial design. The company intends to submit an Investigational New Drug application for CNTY-813 in the fourth quarter of 2026, with the expectation of gathering initial clinical data in the second half of 2027. CNTY-813 leverages Century's proprietary Allo-Evasion 5.0 technology.