Aplagon is developing APAC to enable functioning AVF vascular access for life-saving hemodialysis treatment in patients with end-stage kidney disease.
Approximately 50% of AVFs fail to mature properly.
APAC will be administered locally once when creating the surgical AVF.
AVF – a surgical connection between the artery and vein – is the most preferred vascular access route. AVF maturation is the process in which the newly joined artery and vein dilate and blood flow through AVF significantly increases, enabling successful hemodialysis.
The maturation of AVF fails when there is an insufficient increase in diameter and blood flow in the weeks following surgical creation. Surgical AVF creation and abnormally high flow rates in AVF cause local vascular injury and platelet activation, impairing the AVF maturation process.
Vascular access failure and preceding dysfunction continue to be a leading cause for hospitalization and morbidity in patients with end-stage kidney disease. AVF failure results in repeated surgical and other interventions and a high rate of abandonment, leading to urgent demand of catheter-based vascular access, new AVF creation by surgery and increased costs of care. The FDA has designated hemodialysis vascular access failure as a fast-track indication, i.e., a serious or life-threatening condition for which there is no effective treatment.
In the U.S. alone, approximately 130,000 new AVFs are created each year and the annual cost of managing hemodialysis vascular access dysfunction is estimated to be USD 2.9 billion.
AVF maturation failure is an orphan indication with high unmet medical need