FDA Grants Vonapanitase Breakthrough Therapy Status for Hemodialysis Use

Proteon expects to report findings from PATENCY-2 and submit a biologics license application to the FDA in 2019
Proteon expects to report findings from PATENCY-2 and submit a biologics license application to the FDA in 2019

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to vonapanitase (Proteon Therapeutics) for increasing arteriovenous fistula secondary patency and improving use for hemodialysis.

Patients on hemodialysis require a high-flow vascular access to connect the patient's bloodstream to the dialysis machine. The preferred form is a radiocephalic arteriovenous fistula which connects a vein to an artery in the patient's forearm, resulting in a substantial increase in blood flow and vein dilation. Vonapanitase, an investigational drug, is designed to improve fistula secondary patency (eg, survival of the fistula without abandonment) and use for hemodialysis. 

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The Breakthrough Therapy designation was based on data from the PATENCY-1 study, the first Phase 3 trial evaluating vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula. The primary endpoint of improving primary patency was not met, however, data showed that vonapanitase demonstrated clinically meaningful improvements in secondary patency and use for hemodialysis.

A second Phase 3 trial for vonapanitase in hemodialysis patients, PATENCY-2, is currently ongoing and is expected to complete enrollment in the first quarter of 2018. The co-primary endpoints are secondary patency and fistula use for hemodialysis. Proteon expects to report findings from PATENCY-2 and submit a BLA to the FDA in 2019.

For more information visit Proteontherapeutics.com.