Cytoki Pharma announced promising initial findings on Tuesday for its investigational lipidated IL-22 analogue, CK-0045, bolstering its prospects for further development in treating type 2 diabetes and obesity. CEO Rasmus Jørgensen stated, “We believe CK-0045 presents a unique opportunity to address obesity and type 2 diabetes, either alone or in combination.”
Cytoki Pharma
CK-0045, an analogue of the non-immunomodulatory cytokine IL-22, specifically targets epithelial cells in the gut and liver. According to the biotech firm, the drug’s mechanism of action, which mimics endogenous IL-22, holds potential for treating a range of metabolic and inflammatory conditions. Previous preclinical studies in mice demonstrated weight loss and enhanced glucose regulation.
The latest data originates from a Phase I study involving 76 healthy participants and those with obesity, highlighting improvements in crucial cardiometabolic parameters. Cytoki indicated that the trial successfully demonstrated target engagement through biomarkers derived from the liver and gut. Pharmacokinetic data supported the feasibility of administering CK-0045 via weekly subcutaneous doses. Moreover, dose-dependent reductions in body mass and enhancements in low-density lipoprotein cholesterol, insulin levels, and insulin resistance were noted, particularly in participants with decreased insulin sensitivity. Furthermore, CK-0045 exhibited a favorable safety profile, with no significant gastrointestinal adverse effects reported.
Cytoki Pharma highlighted that these results warrant advancing CK-0045 into Phase II trials, expected to commence in the latter half of this year. Founded in 2019 by Jørgensen, formerly of Novo Nordisk’s research division, Cytoki licensed CK-0045 from Novo and positioned it as the company’s flagship asset.
