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news.Proteon Therapeutics has reported positive results from Phase 2 trial of PRT-201 conducted in chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF) for hemodialysis.
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The double-blind, placebo-controlled study randomized 151 patients with either one of two doses of PRT-201, or placebo to evaluate the safety and efficacy of PRT-201 delivery subsequent to the surgical creation of an AVF.
PRT-201 was well tolerated at the tested doses in the Phase 2 study
The investigational candidate prolonged primary unassisted patency and improved 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.
"This results in poorer outcomes and significantly increases morbidity and cost," Roy-Chaudhury added.
"In this context, the safety and efficacy results of this Phase 2 study are very encouraging and warrant further evaluation of PRT-201 in this patient population."
The duration of unassisted primary patency was the primary endpoint while AVF maturation was a secondary efficacy endpoint.