Clinical Trials

Vicore Pharma Holding AB has announced that it has dosed the first patient with C21 in its randomised, double-blind, placebo-controlled, cross-over clinical study of endothelial dysfunction. The trial includes patients with type 2 diabetes mellitus (T2DM), a condition in which endothelial dysfunction is significant in the development of organ damage.

This trial will use Vicore’s first ATRAG C21 and EndoPAT, a US Food and Drug Administration (FDA) approved, non-invasive, simple and robust technology in order to detect endothelial dysfunction. Results from the trial are expected in the fourth quarter of 2023. It is hoped that if the proof-of-principal is achieved, the results may strengthen the idea that ATRAGs can be useful in the treatment of multiple major common diseases, as well as demonstrate that the EndoPAT technique can be used in exploring therapeutic efficacy in diseases impacted by endothelial dysfunction.

Elin Rosendahl, vice president of Clinical Operations at Vicore Pharma, commented: “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.”

Jan Nilsson, professor in Experimental Cardiology at Lund University, Sweden and principal investigator in the trial, added: “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.”