Cytoki Pharma Reveals Promising Phase 1 Results for CK-0045 in Cardiometabolic Risk Reduction

Cytoki Pharma, a clinical-stage biotechnology firm based in Copenhagen, Denmark, has announced promising results from a Phase 1 study of their lead candidate, CK-0045. The study focused on evaluating the safety, tolerability, and pharmacokinetics of CK-0045 in both healthy participants and those with obesity. CK-0045, a lipidated interleukin-22 (IL-22) candidate, demonstrated significant potential in addressing key metabolic parameters such as body weight, cholesterol, blood glucose levels, and insulin sensitivity.

According to Rasmus Jorgensen, Ph.D., the Founder and CEO of Cytoki Pharma, there is an ongoing need for treatments that promote sustainable weight loss and broader metabolic benefits. CK-0045 is seen as a unique opportunity to address these needs, either as a standalone treatment or in combination with other therapies. The company is encouraged by the initial data which supports CK-0045's distinct mechanism of action.

IL-22 is a cytokine that specifically targets epithelial tissues like the gut and liver without modulating the immune system. Preclinical data had previously shown that lipidated IL-22 could reduce body weight and improve glucose balance in mice via a novel mechanism. The Phase 1 study results indicate similar effects in humans, evidenced by target engagement based on liver and gut biomarkers. The pharmacokinetic data suggest that weekly subcutaneous dosing of CK-0045 is feasible.

CK-0045 induced reductions in body mass in an exposure-dependent manner and also contributed to beneficial decreases in low-density lipoprotein cholesterol, blood insulin levels, and insulin resistance, especially in participants with reduced insulin sensitivity. The drug was generally well-tolerated, with most side effects being mild skin reactions, and there were no significant gastrointestinal issues reported.

Given these positive findings, Cytoki Pharma plans to advance CK-0045 into Phase 2 proof-of-concept studies in individuals with obesity and type 2 diabetes. The Phase 2 studies are expected to begin in the latter half of 2024.

CK-0045 is an advanced, long-acting variant of IL-22, designed to selectively target epithelial cells. The compound, licensed from Novo Nordisk A/S, utilizes validated technology to enhance the pharmacological properties of the natural IL-22 protein, creating a first-in-class therapy that could address a wide range of metabolic diseases, including obesity and type 2 diabetes, as well as conditions like inflammatory bowel disease characterized by epithelial injury. CK-0045 has undergone rigorous evaluation in a randomized, double-blind, placebo-controlled Phase 1 study to investigate its safety, tolerability, and pharmacokinetics in both healthy individuals and those with obesity.

Cytoki Pharma, founded in 2019, is driven by a team of pharmaceutical industry veterans with extensive experience in drug discovery and clinical development. The company is dedicated to pioneering a new class of medicines that leverage IL-22 biology to improve outcomes for metabolic diseases. Alongside CK-0045, Cytoki Pharma is also developing a broader range of IL-22-based treatments for metabolic diseases and inflammatory bowel disease. The anticipated start of Phase 2 studies for CK-0045 in the second half of 2024 marks a significant milestone for the company and its innovative approach to treating metabolic disorders.