Proteon Therapeutics is a late-stage biopharmaceutical company committed to improving the lives of patients and families affected by kidney and vascular diseases. Our goal is to address some of the most urgent needs of patients by developing potentially transformative solutions that redefine how these diseases are treated. Our lead product candidate, vonapanitase, is a first-in-class, investigational drug intended to treat vessel injury that leads to blood vessel blockage and reduced blood flow. Vonapanitase is currently being evaluated in a pivotal Phase 3 clinical study in hemodialysis vascular access. Vonapanitase has received breakthrough, 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.
For people with chronic kidney disease (CKD) requiring hemodialysis, a functioning vascular access is their lifeline to care, enabling connection to a dialysis machine three times per week for life-saving blood cleansing. The preferred form of vascular access is a radiocephalic arteriovenous fistula created in the forearm. Unfortunately, up to 40% of radiocephalic fistulas will be abandoned within one year of surgical creation and more than 50% will fail to be used for hemodialysis. The clinical consequences of fistula abandonment are severe, including a reduction in dialysis adequacy, one or more surgical procedures to create a new vascular access, and prolonged exposure to dialysis catheters, the worst form of vascular access due to the increased risk of infection, hospitalization and death. We are currently conducting a pivotal Phase 3 clinical trial evaluating whether a single topical administration of investigational vonapanitase can improve radiocephalic fistula outcomes. We are not aware of any products approved in the U.S. or Europe that would compete with vonapanitase for the improvement of secondary patency (time to abandonment) and fistula use for hemodialysis.
Vonapanitase is also being studied in patients with peripheral arterial disease (PAD). Patients with PAD suffer from a blockage in the arteries providing blood to the legs, which may result in impaired walking ability, leg pain and gangrene, and ultimately 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, symptom recurrence and disease progression. Building on prior Phase 1 results, our current Phase 1 clinical trial is evaluating whether a single local administration of vonapanitase can reduce the symptoms of PAD in patients undergoing angioplasty of an artery below the knee.