Investigational Drug May Improve Vascular Access in Hemodialysis

Proteon Therapeutics announced results from a Phase 2 clinical trial of PRT-201 to use to prolong the patency and reduce the failure of hemodialysis vascular access in patients with chronic kidney disease (CKD). PRT-201 is a locally-acting recombinant human elastase delivered to the external surface of the artery and vein during surgical creation of an arteriovenous fistulas (AVF).

The Phase 2 study was the third multicenter, double-blind, placebo-controlled trial of PRT-201 in 151 patients undergoing surgical placement of a vascular access. Results indicate that PRT-201 may improve function and durability of AVFs, the optimal form of vascular access for hemodialysis patients. A single treatment of PRT-201 may also increase the longevity of an AVF, reducing the need for additional corrective surgical and interventional procedures.

PRT-201 demonstrated improvement in key measures of AVF function, including an increased percentage of AVFs that developed adequate blood flow for dialysis without the need for an intervention within 12 weeks of creation and a decrease in the percentage of AVFs that developed a thrombosis or required a procedure to restore or maintain patency within one year.

The FDA had previously granted PRT-201 Fast Tract and Orphan Drug designations. Based on the results of this study, Proteon plans to initiate a Phase 3 study in 2014. 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.

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