Cytoki Pharma Begins Phase 2 Dosing of CK-0045 for Obesity and Type 2 Diabetes

Cytoki Pharma, a clinical-stage biotechnology firm based in Copenhagen, Denmark, has initiated a Phase 2 proof-of-concept trial to assess the efficacy, safety, and tolerability of CK-0045, their lead lipidated IL-22 analogue. This study will focus on patients with obesity and type 2 diabetes, conditions that collectively affect over a billion people globally.

Anne Louise Kjølbye, Ph.D., MBA, Chief Development Officer at Cytoki, highlighted the urgency of addressing obesity and diabetes, noting the limitations of current incretin-based treatments. She emphasized the potential of CK-0045 to not only aid in weight loss but also to provide additional cardiometabolic benefits that could extend healthy lifespans.

CK-0045 is designed using lipidation technology, which prolongs its circulation time in the body and allows for subcutaneous delivery. This innovation is expected to make CK-0045 a pioneering treatment for metabolic diseases. The Phase 1 clinical trials demonstrated promising results, showing reductions in body mass, improvements in LDL cholesterol, blood insulin levels, and insulin resistance. These findings, coupled with a favorable safety profile, have paved the way for further clinical development.

Dr. Carel le Roux, Professor of Experimental Pathology at University College Dublin, expressed optimism about the ongoing clinical evaluation of CK-0045. He underscored the unique mechanism of action involving IL-22 and its potential as a transformative treatment for obesity and type 2 diabetes.

The Phase 2 study, identified by the clinical trial number NCT06611930, will be a 16-week randomized, double-blind, placebo-controlled trial involving 90 participants. The study will explore two different doses of CK-0045, administered once a week via subcutaneous injections. The primary outcomes being measured include weight loss, changes in HbA1c levels, insulin sensitivity, and lipid profiles. Results from this study are expected in the first half of 2026.

In addition to CK-0045, Cytoki is advancing a diverse portfolio of IL-22-based therapies aimed at addressing unmet needs in metabolic diseases and inflammatory bowel disease. These efforts are part of the company's broader strategy to develop innovative treatments leveraging the therapeutic potential of IL-22.

CK-0045 itself is a long-acting analogue of interleukin-22, a cytokine that selectively targets epithelial cells without modulating the immune system. This analogue was licensed from Novo Nordisk A/S and incorporates validated technology to enhance the pharmacologic properties of IL-22. This optimization aims to create a first-in-class therapy addressing a wide range of metabolic disorders, including obesity, type 2 diabetes, and conditions characterized by epithelial damage, such as inflammatory bowel disease.

Earlier, CK-0045 was evaluated in a Phase 1 clinical trial (NCT05712876), which investigated its safety, tolerability, and pharmacokinetics in healthy individuals, including those with obesity. The current Phase 2 trial (NCT06611930) builds on these findings and aims to further establish CK-0045's potential benefits for patients with type 2 diabetes and obesity.

Founded in 2019, Cytoki Pharma is dedicated to pioneering a new class of medicines that leverage IL-22 biology for improved cardiometabolic outcomes. The company is led by a team of seasoned pharma industry professionals with extensive experience in drug discovery and clinical development. As Cytoki continues to advance its lead program, CK-0045, and other IL-22-based assets, it remains focused on addressing significant unmet medical needs in metabolic and inflammatory diseases.