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
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.
