Proteon's vonapanitase receives breakthrough therapy designation

Proteon Therapeutics Inc. (NASDAQ:PRTO) said FDA granted breakthrough therapy designation to vonapanitase to increase arteriovenous fistula (AVF) secondary patency in patients on or expected to start hemodialysis.

The recombinant human elastase is in the Phase III PATENCY-2 trial in patients with chronic kidney disease (CKD) undergoing surgery for AVF creation. Earlier this month, the company increased the trial's target enrollment from 500 to 600 to correct a calculation error in the trial's statistical plan (see BioCentury, May 15)...