US-based Proteon Therapeutics has reported that its investigational drug vonapanitase failed to meet co‐primary endpoints in a Phase III clinical trial performed in patients with chronic kidney disease (CKD).
The PATENCY‐2 trial enrolled patients undergoing surgical creation of a radiocephalic arteriovenous fistula for haemodialysis. Its co‐primary endpoints were fistula use for haemodialysis and secondary patency.
Vonapanitase is being developed to improve haemodialysis vascular access outcomes. The Phase III trial assessed the candidate’s safety and efficacy in 603 subjects at 39 sites across the US and Canada.
According to the top-line results, 69.7% of participants treated with vonapanitase experienced use of the fistula for haemodialysis, compared to 65.1% of those given placebo.
This does not indicate a statistically significant difference between the arms, and so the trail failed to meet this co-primary endpoint.
Measurements for secondary patency also revealed no statistically significant difference, with 78% of vonapanitase‐treated subjects maintaining the patency versus 76% in placebo arm.
The adverse events in the drug and placebo arms were also similar. The most common adverse events included vascular stenosis, fistula thrombosis, local swelling, and hematoma.
Proteon Therapeutics president and CEO Timothy Noyes said: “We believe this trial was well conducted and are surprised and disappointed by these results.
“In the coming weeks and months, the company intends to review the full data set from PATENCY‐2 and evaluate our strategic options.”
The company also evaluated vonapanitase in another Phase III trial, PATENCY‐1, which involved 311 chronic kidney disease (CKD) patients undergoing surgical creation of a radiocephalic arteriovenous fistula at 31 centres in the US.