Danish biotechnology company Cytoki Pharma has reported positive results from a Phase I trial of CK-0045, a lipidated interleukin-22 (IL-22) candidate.
The study assessed CK-0045’s safety, tolerability and pharmacokinetics in healthy subjects and those with obesity, finding that the drug had the potential to reduce cardiometabolic risk factors.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
It demonstrated CK-0045’s impact on several metabolic parameters, including reductions in body weight, cholesterol levels and blood glucose, as well as improved insulin sensitivity.
IL-22 is a non-immunomodulatory cytokine that acts on epithelial tissues such as the gut and liver.
In preclinical studies, the lipidated IL-22 was shown to reduce body weight and improve glucose homeostasis in mice through a unique mode of action.
Cytoki Pharma said the Phase I results have successfully translated these preclinical findings to humans, with evidence of target engagement based on biomarkers from the liver and gut.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataPharmacokinetic data have confirmed the feasibility of once-weekly subcutaneous dosing of CK-0045.
The drug also induced reductions in body mass that correlated with decreases in low-density lipoprotein cholesterol, insulin resistance and blood insulin concentration, especially in participants with reduced insulin sensitivity.
CK-0045 was found to be generally well-tolerated in the trial, with the majority of participants completing the dosing regimen.
Cytoki Pharma founder and CEO Rasmus Jorgensen said: “As the obesity treatment landscape continues to evolve, there remains a need for approaches that drive lasting disease modification through healthy weight loss and broader, deeper weight loss-independent metabolic effects.
“We believe CK-0045 offers a differentiated opportunity to address obesity and type 2 diabetes (T2D), either as monotherapy or in combination with other clinical approaches and are encouraged by these first data supporting CK-0045’s unique mechanism of action.”
Based on the clinical data, Cytoki Pharma plans to advance CK-0045 into Phase II proof-of-concept studies targeting individuals with obesity and T2D later this year.
