Proteon Therapeutics Inc. announced the results from its Phase 3 PATENCY-1 clinical trial of investigational vonapanitase. The study results suggested vonapanitase may improve both fistula use for hemodialysis and secondary patency (time to fistula abandonment), which are the co-primary endpoints in Proteon’s ongoing Phase 3 PATENCY-2 clinical trial. The PATENCY-2 clinical trial is fully enrolled and top-line data is expected in March 2019. PATENCY-1 evaluated the safety and efficacy of a single dose of vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. The randomized, double-blind, placebo-controlled clinical trial enrolled 313 treated patients at 31 medical centers in the United States. Patients were followed for up to one year. Based on the results of PATENCY-1, and following discussions with the FDA, Proteon amended the protocol for the PATENCY-2 trial, reordering the endpoints and establishing fistula use for hemodialysis and secondary patency as co-primary endpoints. If PATENCY-2 is successful in showing statistical significance (p=0.05) for both of the co-primary endpoints, Proteon expects to file a Biologics License Application (BLA) with the FDA in the second half of 2019 and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first half of 2020.