Cytoki Pharma Highlights Data Reinforcing Therapeutic Potential of Lipidated IL-22 for IBD in Digestive Diseases and Sciences Publication

Findings support lipidated IL-22 as a differentiated treatment option to address the significant unmet need in IBD

Results strongly support continued development of Cytoki's oral IL-22 program for UC which is part of its growing preclinical pipeline of IL-22-based assets

SØBORG, Denmark, May 8, 2025 /PRNewswire/ -- Cytoki Pharma ApS (Cytoki), a clinical-stage biotechnology company pioneering a new class of medicines that harness interleukin-22 (IL-22) biology to drive improved metabolic and other health outcomes, today announced the publication of preclinical data demonstrating the efficacy of its novel lipidated IL-22 analogue in a model of inflammatory bowel disease (IBD) in Digestive Diseases and Sciences.

The publication, titled "Lipidated IL-22 Alone or Combined with Immunomodulatory Agents Improves Disease Endpoints and Promotes Mucosal Healing in a Mouse Model of Chronic Dextran Sodium Sulfate-Induced Colitis," includes findings demonstrating the therapeutic potential of a novel lipidated IL-22 analogue in a widely used preclinical IBD model. Findings indicated lipidated IL-22's ability to significantly improve all aspects of chronic colitis, with a clear dose-dependent response in reducing clinical, endoscopic, and histological signs of the disease. Preclinical results also highlighted lipidated IL-22's ability to directly induce mucosal healing and reduce inflammation, further demonstrating IL-22's unique ability when compared to existing IBD treatments. Notably, the combination of lipidated IL-22 with immunomodulatory agents resulted in additive therapeutic benefits, signaling potential for even greater improvements when used in combination.

The translatability of these findings is supported by human data demonstrating increased expression of genes associated with epithelial repair and host defense in colonic biopsies from patients with ulcerative colitis after IL-22 administration. Together, these results suggest a promising new therapeutic strategy for managing IBD and increasing long-term remission rates.

"These compelling findings underscore the significant potential of IL-22's powerful biology to fuel novel therapeutics capable of addressing IBD via a differentiated mode of action," said Martijn van de Bunt, M.D., D.Phil, CSO at Cytoki and publication co-author. "Given IL-22's unique potential to overcome the current therapeutic ceiling in IBD management, we are excited about the preclinical oral IL-22 program we are pursuing alongside our metabolic disease-focused clinical and preclinical IL-22 pipeline."    

Additional key takeaways from the paper are as follows:

• Lipidated IL-22 alone significantly improved clinical signs of colitis, as measured by the Disease Activity Index, as well as endoscopic and histological scores.
• Administration of lipidated IL-22 in combination with commonly used immunomodulators (e.g., anti-TNF antibody) surpassed the efficacy of each monotherapy.
• Histological analysis indicated that lipidated IL-22 treatment had a direct effect on mucosal healing in the colon, as demonstrated by increased epithelial cell proliferation and goblet cell numbers, accompanied by a reduction in CD3+ T-cell infiltration.

About Cytoki Pharma

Cytoki Pharma is a clinical-stage biotechnology company pioneering a new class of medicines that harness IL-22 biology to drive improved outcomes for cardiometabolic disease and inflammatory conditions. Cytoki's lead program, CK-0045, a lipidated IL-22 analogue, is currently being evaluated in a Phase 2 clinical study in individuals with obesity and type 2 diabetes. The company is also advancing a broader portfolio of preclinical IL-22-based assets. Cytoki was founded in 2019 and is led by a team of pharma industry veterans with deep expertise in the discovery and clinical development of novel drugs. Please visit www.cytokipharma.com or follow us on LinkedIn for additional details.

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SOURCE Cytoki Pharma