Proteon Therapeutics has reported positive Phase II trial results of PRT-201 in chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula for hemodialysis.
PRT-201, which was well-tolerated at the tested doses in the Phase II study, has demonstrated that it prolongs primary unassisted patency and improves the rate of AVF maturation.
The University of Cincinnati, Academic Health Center professor of medicine Dr Prabir Roy-Chaudhury said AVF patency loss and non-maturation necessitate multiple endovascular (angioplasty) and surgical procedures to restore or maintain blood flow and resulting in prolonged use of dialysis catheters, which have a very high rate of infection.
"This results in poorer outcomes and significantly increases morbidity and cost," Roy-Chaudhury said.
"In this context, the safety and efficacy results of this Phase II study are very encouraging and warrant further evaluation of PRT-201 in this patient population."
The double-blind study was designed to assess the safety and efficacy of PRT-201 delivery following surgical creation of an AVF.
The placebo-controlled study randomised 151 patients with either one of two doses of PRT-201, or placebo.
The duration of unassisted primary patency, defined as the time from surgical creation of the AVF until thrombosis or the occurrence of a procedure to maintain or restore patency was the primary endpoint, while AVF maturation was a secondary efficacy endpoint.
Proteon president and CEO Timothy Noyes said PRT-201 represents a highly innovative approach to address the challenges associated with vascular access in patients with CKD.
"Based on the positive results from this Phase II study, Proteon intends to advance PRT-201 into Phase III studies," Noyes said.