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.

"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."

"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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.