Proteon Therapeutics has enrolled first patient in the second Phase III clinical study of its investigational product candidate vonapanitase (formerly PRT-201) for chronic kidney disease (CKD).
Vonapanitase is an investigational drug being developed to improve arteriovenous fistula (AVF) patency, the period of time during which an AVF remains open with adequate blood flow to enable haemodialysis.
The second trial is said to complement the first Phase III study that started in July 2014 and is expected to complete enrolment by the end of this year.
Both the Phase III trials have been designed to assess the safety and efficacy of a single treatment of vonapanitase in patients with CKD undergoing surgical creation of a radiocephalic arteriovenous fistula (AVF) for haemodialysis.
The company has enrolled the first patient in the second Phase III trial at Saint Luke’s Hospital of Kansas City in the US.
Proteon Therapeutics president and CEO Timothy Noyes said: "Proteon has its roots in Kansas City and I am thrilled that a local institution enrolled the first patient in this important clinical study evaluating a potential new treatment for patients requiring vascular access."
The second randomised, double-blind and placebo-controlled Phase III clinical trial will enrol 300 patients at around 40 centres in the US and Canada.
Each patient will receive either 30mg of vonapanitase or placebo, immediately after surgical creation of a radiocephalic AVF. It will be delivered in a single and local administration to the external surface of the AVF.
According to the firm, the primary efficacy endpoint, measured over 12 months, is primary patency the time from AVF creation until a thrombosis or a procedure to restore or maintain patency.
Also measured over 12 months, the secondary efficacy endpoint is secondary patency, defined as the time from AVF creation until AVF abandonment.
The company is also carrying out an ongoing Phase I clinical study of vonapanitase in patients with symptomatic peripheral artery disease (PAD).