Proteon Therapeutics Reports Publication of Promising Nonclinical Results from Vonapanitase in Peripheral Artery Disease

Proteon Therapeutics Inc.

, a company developing novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular diseases, today announced publication of additional nonclinical data on investigational drug vonapanitase in peripheral artery disease (PAD). The ex vivo study demonstrated that a single treatment of vonapanitase following angioplasty of excised atherosclerotic human tibial arteries altered artery compliance. Increased compliance is known to correlate with arterial dilation. The study, titled "Recombinant Human Elastase Alters the Compliance of Atherosclerotic Tibial Arteries After Ex Vivo Angioplasty", was published in the Journal of Cardiovascular Pharmacology. Proteon's Senior Vice President and Chief Medical Officer, Steven Burke, M.D., is the senior author of the published manuscript. PAD is often caused by atherosclerosis and can frequently occur in the tibial arteries, which are located below the knee and supply blood to the lower leg and foot. This study was designed to compare the effects of vonapanitase and placebo on excised atherosclerotic human tibial arteries following ex vivo angioplasty. Assessments included elastin content in the arterial wall and arterial compliance, which is a measure of an artery's ability to expand with changes in blood pressure. Data from the study demonstrated that vonapanitase treatment ex vivo reduced elastin content by 60% compared to placebo and altered arterial compliance. Increased compliance is known to correlate with arterial dilation. "Current interventional treatments for patients with PAD below the knee, such as balloon angioplasty, lack durability," said Timothy Noyes, President and Chief Executive Officer of Proteon. "These data published in the Journal of Cardiovascular Pharmacology support our hypothesis that a single, local administration of vonapanitase may augment the effects of balloon angioplasty through enhanced artery dilation." This study supports other clinical and nonclinical results evaluating the potential use of vonapanitase in PAD. Proteon announced in August of 2015 the completion of a Phase 1 PAD clinical study indicating that catheter-based administration of vonapanitase using the Mercator MedSystems Bullfrog® Micro-Infusion Device to the superficial femoral or popliteal artery following angioplasty was generally well tolerated and technically feasible. Proteon announced in January of 2015 the publication of nonclinical data demonstrating that vonapanitase treatment of atherosclerotic human tibial arteries ex vivo without prior angioplasty resulted in an increase in artery diameter. Based on these data and other nonclinical results, Proteon expects to initiate two Phase 1 clinical studies in PAD in 2016. Proteon is also currently conducting two Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical studies of vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation an arteriovenous fistula (AVF) for hemodialysis vascular access. Data from the first Phase 3 study is expected in December of 2016.