Proteon ups Phase III PATENCY-2 enrollment

Proteon Therapeutics Inc. (NASDAQ:PRTO) will for the second time increase enrollment in the ongoing Phase III PATENCY-2 trial of vonapanitase to treat chronic kidney disease (CKD) to correct a calculation error in the trial’s statistical plan. The trial will now enroll 600 CKD patients undergoing surgery for arteriovenous fistula (AVF) creation, up from 500 previously. Proteon said the error had overstated the trial’s power to evaluate the co-primary endpoint of secondary patency, defined as the time from creation until fistula abandonment. The trial’s other co-primary endpoint will assess fistula use for hemodialysis.

The double-blind, placebo-controlled, North American trial is evaluating vonapanitase given immediately after radiocephalic AVF. Vonapanitase is recombinant human elastase...