Positive Phase 1 Data for Cytoki Pharma’s Obesity and Diabetes Candidate CK-0045

Cytoki Pharma, a biotechnology company, has announced positive data from a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of CK-0045, its lead lipidated IL-22 candidate, in healthy participants and those with obesity. The study showed the effect of CK-0045 on several key metabolic parameters, including body weight, cholesterol, blood glucose levels, and insulin sensitivity.

 The company believes CK-0045 offers a differentiated opportunity to address obesity and type 2 diabetes, either as monotherapy or in combination with other clinical approaches. IL-22, a non-immunomodulatory cytokine, selectively targets epithelial tissues like the gut and liver. The Phase 1 study confirmed target engagement based on liver and gut-derived biomarkers and confirmed the feasibility of once weekly subcutaneous dosing. CK-0045 induced exposure-dependent reductions in body mass, low-density lipoprotein cholesterol, blood insulin concentration, and insulin resistance, particularly in participants with reduced insulin sensitivity.

The most commonly occurring side effects were mild skin reactions, and a notable absence of substantial gastrointestinal effects was observed. The available clinical data support advancement of CK-0045 into Phase 2 proof-of-concept studies in individuals with obesity and type 2 diabetes to further assess the clinical relevance of observed effects.