Proteon Therapeutics Initiates Phase 3 Clinical Study of PRT-201 in Patients with Chronic Kidney Disease Undergoing Surgical Placement of an Arteriovenous Fistula for Hemodialysis
WALTHAM, Mass. — July 21, 2014 — Proteon Therapeutics Inc., a privately held biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases, announced today that the first patient has been treated in a pivotal Phase 3 clinical study of its lead product, PRT-201, in chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF). PRT-201, a locally-acting recombinant human elastase, is an investigational drug that may prolong the patency and reduce the failure of hemodialysis vascular access in patients with CKD. PRT-201 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.
“Hemodialysis is a life-saving treatment for patients with CKD, but many of these patients suffer from vascular access failure, which can result in repeated surgical and interventional procedures,” said Timothy Noyes, President and Chief Executive Officer of Proteon. “We believe that a single treatment of PRT-201 at the time of AVF surgical placement has the potential to reduce AVF failure.”
A functioning vascular access is a hemodialysis patient’s lifeline, enabling the patient to undergo hemodialysis. The optimal form of vascular access, a radiocephalic AVF, is created in a surgical procedure in which the cephalic vein is sutured to the radial artery near the wrist, resulting in an increase in blood flow sufficient for hemodialysis. Unfortunately, within one year of surgical creation, up to 70 percent of radiocephalic AVFs experience patency loss, in which the AVF suffers from inadequate blood flow, precluding adequate hemodialysis. Patency loss can lead to additional surgical or interventional procedures to improve blood flow, AVF abandonment, prolonged exposure to dialysis catheters, and higher costs of care.
The randomized, double-blind, placebo-controlled Phase 3 clinical trial will enroll 300 patients at approximately 30 centers in the United States. Immediately after surgical placement of a radiocephalic AVF, each patient will receive either 30 micrograms of PRT-201 or placebo, delivered in a single, local administration to the external surface of the AVF. The primary efficacy endpoint is primary unassisted patency, which is the same primary endpoint studied in a Phase 2 trial of PRT-201. Primary unassisted patency is defined as the time from AVF creation until a thrombosis or a procedure to restore or maintain patency. The secondary efficacy endpoint is secondary patency, defined as AVF abandonment.
The Phase 3 study follows the successful completion of a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical trial in which 151 patients were treated. Results from this study indicated an improvement in key measures of AVF function in patients treated with PRT-201, and adverse events were comparable to placebo.
Proteon is also investigating PRT-201 as a treatment for patients with symptomatic peripheral artery disease (PAD) and is currently enrolling patients in a Phase 1 clinical study in the United States.
PRT-201 is an investigational recombinant human elastase that is being studied for its ability to improve outcomes in patients suffering from vascular disease. Elastase has been shown in preclinical settings to reduce neointimal hyperplasia formation, which may result in improved blood flow and prolonged vessel patency. PRT-201 has received fast track and orphan drug designations from the FDA and orphan medicinal product designation from the European Commission for hemodialysis vascular access indications.
About Proteon Therapeutics
Proteon Therapeutics Inc. is a privately held biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases. The company is headquartered in Waltham, Mass. For additional information, please visit www.proteontherapeutics.com.
Timothy Noyes, President and Chief Executive Officer
Chris Erdman, MacDougall Biomedical Communications
# # #