Proteon Therapeutics Announces Publication of Results from Phase 3 PATENCY-1 Clinical Trial

Proteon Therapeutics (Nasdaq:PRTO), a company developing novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular diseases, today announced the publication in the Journal of Vascular Surgery of results from its Phase 3 PATENCY-1 clinical trial of investigational vonapanitase.

As quoted in the press release:

Top-line data from PATENCY-1 were publicly announced in December 2016. 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.

As previously reported, PATENCY-1 did not meet its primary endpoint of improved primary unassisted patency, compared to placebo (p=0.254). However, for its pre-specified secondary endpoint, the trial showed a 34% reduction in the risk of secondary patency loss over one year, compared to placebo (p=0.048). Additionally, the trial showed a 45% relative increase in fistula use for hemodialysis, compared to placebo (p=0.006), which was another pre-specified endpoint.

Click here to read the full press release.