The study is assessing C21 effect on endothelial dysfunction in type-2-diabetes-mellitus patients. Credit: National Human Genome Research Institute (NHGRI) from Bethesda, MD, USA / commons.wikimedia.org.

Vicore has dosed the first patient in a study assessing the effect of its angiotensin II type 2 receptor agonist (ATRAG) C21 on endothelial dysfunction in type-2-diabetes-mellitus patients.

A simple, non-invasive FDA-approved technology, EndoPAT is used for identifying endothelial dysfunction in the proof-of-concept, double-blind, randomised, placebo-controlled, cross-over study.

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It can also be used to investigate therapeutic efficacy in diseases driven by endothelial dysfunction and determine the active dose-range for new ATRAGs.

Vicore Pharma clinical operations vice-president Elin Rosendahl said: “Measuring endothelial dysfunction with the EndoPAT technology in drug trials is a cost-effective and robust method for early documentation of proof-of-concept in pulmonary, renal and vascular diseases.

“This has the potential to substantially shorten the timelines and decrease the risk in clinical development programmes.”

Endothelial dysfunction is a key driver of organ damage and is characterised by a proinflammatory and prothrombotic state with impaired microvascular blood flow.

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Lund University experimental cardiology professor and trial principal investigator Jan Nilsson said: “Patients with diabetes mellitus have an increased risk of cardiovascular events and endothelial dysfunction is an important factor for this development.

“Treating endothelial dysfunction could be a major breakthrough in cardiovascular disease.”

Results from the trial are expected in the fourth quarter of this year.