Proteon Therapeutics is a late-stage biopharmaceutical company committed to improving the lives of patients and families affected by kidney and vascular diseases. We are developing potentially transformative solutions to address some of the most urgent needs of patients with chronic kidney disease (CKD) requiring hemodialysis and peripheral artery disease (PAD) with the goal of redefining how these diseases are treated. Our lead product candidate, vonapanitase, is a first-in-class, Phase 3 investigational drug designed to treat vessel injury that leads to blood vessel blockage and reduced blood flow. These complications can prevent a patient from undergoing life-saving hemodialysis and result in corrective procedures, excess costs and patient trauma.
For people on hemodialysis, vascular access is their lifeline to care, enabling connection to a dialysis machine three times per week for life-saving blood cleansing. Approximately two-thirds of patients in the U.S. on hemodialysis gain vascular access through an arteriovenous fistula. Unfortunately, up to 70% of radiocephalic arteriovenous fistulas in the U.S. fail within the first year, and we are not aware of any approved preventative treatments to reduce the failure rate of fistulas. We are currently investigating vonapanitase in a Phase 3 program in patients with CKD undergoing surgical creation of a radiocephalic arteriovenous fistula. The trial is evaluating whether a single topical administration of investigational vonapanitase can improve radiocephalic fistula patency. Investigational vonapanitase has received fast track and orphan drug designations from the U.S. Food and Drug Administration (FDA) and orphan medicinal product designation from the European Commission for hemodialysis vascular access indications.
Proteon is also investigating vonapanitase in patients with PAD. PAD patients experience a blockage in the arteries providing blood to the legs, and can suffer from impaired walking function, leg pain and gangrene, and may require amputation. Many patients undergo invasive revascularization procedures to treat the blockage, but these procedures have poor long-term durability resulting in the potential for repeat interventions and the risk of disease progression. Building on prior Phase 1 results, Proteon is conducting two additional Phase 1 clinical trials evaluating whether a single local administration of vonapanitase can reduce the symptoms of PAD