Proteon Launches Second Phase 3 Study of Vonapanitase
Proteon Therapeutics has enrolled its first patient in a second Phase 3 clinical study evaluating vonapanitase as a guard against vascular access failure in hemodialysis patients.
The clinical trial will assess the safety and efficacy of a single treatment of vonapanitase in 300 patients with chronic kidney disease who are undergoing surgery to create an arteriovenous fistula where the dialysis accesses the patient’s blood. The primary endpoint, measured over 12 months, is the time from AVF creation until a blood clot forms or a procedure is required to restore or maintain patency.
According to Proteon, there are no approved therapies to prolong AVF patency — the time an AVF remains open with adequate blood flow to enable hemodialysis. Vonapanitase, a locally acting recombinant human elactase, has received fast-track and orphan drug designations from the FDA and an orphan designation from the European Commission for hemodialysis vascular access indications.
An initial phase 3 trial began in July 2014 and is expected to complete enrollment by the end of the year.
Proteon says the drug could have other surgical and endovascular applications where vessel injury could lead to blockages and reduced blood flow. Vonapanitase is being evaluated in a phase 1 clinical trial of patients with symptomatic peripheral artery disease. — John Bechtel