Vicore Pharma, a Swedish clinical-stage pharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists (ATRAGs), has dosed its first patient with C21 in a clinical study of endothelial dysfunction.
Vicore Pharma states that results from the trial are expected in Q4, 2023.
Vicore is conducting a randomised, double-blind, placebo-controlled, cross-over trial evaluating the effect of ATRAGs on endothelial dysfunction (reflecting blood vessel health) in patients with type-2-diabetes-mellitus (T2DM)1, a condition where endothelial dysfunction is central in the development of organ damage.
The trial will be conducted with Vicore’s first ATRAG C21 and will use EndoPAT2, an FDA approved, non-invasive, simple, and robust technology to detect endothelial dysfunction.
If proof-of-principle is reached, this would both strengthen the view that ATRAGs may be useful in several major common diseases, and that the EndoPAT technique can be used for exploring therapeutic efficacy in diseases driven by endothelial dysfunction as well as for establishing the active dose-range for new ATRAGs.
Endothelial dysfunction is characterised by a proinflammatory and prothrombotic state with impaired microvascular blood flow, and it is a vascular hallmark of several common diseases. There is currently no treatment for endothelial dysfunction and counteracting this vascular disturbance is likely to reduce cardiovascular, renal and other complications associated with, for example diabetes and ageing.
Furthermore, endothelial dysfunction plays a central role in pulmonary arterial hypertension and preeclampsia, two microvascular diseases where ATRAGs have been proposed as a novel therapeutic approach and where there is strong preclinical support.
“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” says Elin Rosendahl, VP Clinical Operations, Vicore Pharma. “This has the potential to substantially shorten the timelines and decrease the risk in clinical development programmes.”
“Patients with diabetes mellitus have an increased risk of cardiovascular events and endothelial dysfunction is an important factor for this development” said Jan Nilsson, Professor in Experimental Cardiology, Lund University, and principal investigator in the trial. “Treating endothelial dysfunction could be a major breakthrough in cardiovascular disease”.