Vicore begins vital endothelial dysfunction study

The wide-ranging research aims to unlock the potential of angiotensin II type 2 receptor agonists

Vicore Pharma has announced that the first patient has been dosed with its C21 candidate during a pivotal clinical study of endothelial dysfunction.

The aim of the research is to unlock the potential of a new class of drugs – angiotensin II type 2 receptor agonists (ATRAGs).

The company is undertaking a randomised, placebo-controlled, cross-over trial evaluating the impact of ATRAGs on endothelial dysfunction among patients with type 2 diabetes mellitus – a condition where endothelial dysfunction is significant in the development of organ damage.

The study will be conducted with Vicore’s first ATRAG C21 and will also incorporate EndoPAT – an FDA-approved, non-invasive technology designed to detect endothelial dysfunction.

Following the initial patient being dosed, results from the trial are expected later this year. If the research yields evidential proof-of-principle, it would both strengthen the view that ATRAGs may be useful across various major common diseases, while also endorsing the EndoPAT technique.

Indeed, this would uphold the exploration of therapeutic efficacy in diseases driven by endothelial dysfunction and establish the active dose-range for new ATRAGs.

Jan Nilsson, professor in experimental cardiology at Lund University and principal investigator in the trial, explained: “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.”

Elin Rosendahl, vice president of clinical operations at Vicore Pharma, reflected: “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.”

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

Endothelial dysfunction involves a prothrombotic and proinflammatory state with impaired microvascular blood flow. In addition, endothelial dysfunction plays a central role in pulmonary arterial hypertension and preeclampsia, two microvascular diseases where ATRAGs have been highlighted as a novel therapeutic approach. There is currently no treatment for the condition.