Cytoki Pharma announces positive data from phase 1 study of lead lipidated IL-22 candidate, CK-0045 in obesity patients

Cytoki Pharma, ApS reported positive Phase 1 results for CK-0045, a lipidated IL-22 candidate, in healthy participants and those with obesity. The study evaluated CK-0045’s safety, tolerability, and pharmacokinetics, revealing its impact on body weight, cholesterol, blood glucose levels, and insulin sensitivity.

IL-22 targets epithelial tissues like the gut and liver. Preclinical data showed it could reduce body weight and improve glucose metabolism. Phase 1 results confirmed these benefits in humans, with CK-0045 showing effective target engagement and supporting weekly subcutaneous dosing. It significantly reduced body mass and improved lipid and glucose profiles.

CK-0045 was well-tolerated, with minor skin reactions and no major gastrointestinal issues. The study paves the way for Phase 2 trials in obesity and type 2 diabetes, expected to start in late 2024. CK-0045, a long-acting IL-22 analogue from Novo Nordisk, aims to treat various metabolic diseases and epithelial injuries.