Cytoki Pharma has announced the first patient has received CK-0045 in a Phase 2 proof-of-concept trial evaluating efficacy, safety and tolerability in individuals with obesity and type 2 diabetes (T2DM).
CK-0045 is a long-acting analogue of interleukin-22 (IL-22), an atypical, non-immunomodulatory cytokine that selectively targets epithelial cells. In-licensed from Novo Nordisk A/S, CK-0045 incorporates validated technology to optimise the pharmacologic properties of the endogenous IL-22 protein to create a differentiated, first-in-class therapy with potential to address a broad range of metabolic diseases, including obesity and type 2 diabetes, and conditions characterised by epithelial injury, such as inflammatory bowel disease. CK-0045 has been evaluated in a randomized, double-blind, placebo-controlled Phase 1 study designed to investigate its safety, tolerability, and pharmacokinetics in healthy individuals with and without obesity.
Results from the Phase 1 clinical study of CK-0045 in healthy volunteers confirmed target engagement and exposure-dependent reductions in body mass, alongside improvements in low-density lipoprotein (LDL) cholesterol, blood insulin levels, and insulin resistance. These results, combined with a favourable safety profile, support further clinical advancement of CK-0045.
"Encouraging results from the Phase 1 study of CK-0045 demonstrate the potential of its unique IL-22 based mechanism of action as a powerful new therapeutic approach to address obesity and type 2 diabetes," said Dr Carel le Roux, Professor of Experimental Pathology, University College Dublin. "We eagerly anticipate Cytoki's progress as it continues clinical evaluation of CK-0045 and develops its broader IL-22-derived pipeline to deliver novel treatments for metabolic disease."
The 16-week randomised, double-blind, placebo-controlled Phase 2 study will evaluate the efficacy, safety and tolerability of two doses of CK-0045, administered subcutaneously once a week, in 90 patients with obesity and type 2 diabetes. The outcomes investigated in the study reflect the wide range of metabolic benefits of IL-22 modulation and include amongst others weight loss, change in HbA1c, insulin sensitivity measurements, and lipid levels. Results of the study are anticipated in the first half of 2026.
Additionally, Cytoki continues to advance a robust portfolio of IL-22-based assets targeting high unmet need in metabolic disease as well as inflammatory bowel disease.
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