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Vicore Pharma Holding has reported that its clinical study investigating the EndoPAT technology as a tool to assess the effect of C21 on endothelial function is complete and that the data were inconclusive.
- Purpose was to test the utility of the EndoPAT technology to study pharmacological vasodilation.
- Results were inconclusive due to high intra-individual variability.
The study was designed as a single-dose, double-blind, exploratory crossover trial to compare the ATRAG C21 with placebo in eleven patients with type 2 diabetes. However, the intra-individual variability in the EndoPAT assessments was high, including between placebo and baseline readings in the primary measure, reactive hyperemia index score, resulting in inconclusive data.
EndoPAT is a diagnostic device that measures endothelium-dependent reflex hyperemia after short-term occlusion of the blood flow to the arm. It is a simple and non-invasive technique that if successful could have facilitated the comparison of efficacy of different ATRAGs and also for assessment of acute effects on endothelial function in various diseases.
Carl-Johan Dalsgaard, CEO of Vicore said: “There is limited experience with EndoPAT in interventional trials and even though we had good hopes for this technology, we have concluded that it is not useful to capture the short-term pharmacological effects we have seen in the human forearm blood-flow study and in systemic sclerosis patients. This finding has no impact on Vicore's continued work with ATRAGs.”