We have completed scientifically rigorous clinical trials with vonapanitase in multiple potential indications.
Arteriovenous Fistula Patency for Hemodialysis Patients
Proteon has completed two multicenter, double-blind, placebo-controlled clinical trials in patients undergoing surgical creation of an arteriovenous fistula for hemodialysis: a 151-patient Phase 2 clinical trial and a 66-patient Phase 1/2 clinical trial.
The Phase 2 clinical trial evaluated safety and efficacy of a single application of investigational vonapanitase delivered immediately after surgical creation of a radiocephalic arteriovenous fistula at the wrist or a brachiocephalic arteriovenous fistula at the elbow.
For the 30 mcg vonapanitase dose as compared to placebo, the study demonstrated the following results for all fistulas:
A non-statistically significant trend of prolonged primary unassisted patency, the trial’s primary endpoint, over more than three years of follow-up
A statistically significant improvement in AVF maturation at 12 weeks
A statistically significant improvement in the rate of corrective procedures over more than three years of follow-up
An analysis of the results for 30 mcg vonapanitase as compared to placebo in the subset of patients receiving a radiocephalic fistula, which was pre-specified for fistula maturation but was not otherwise pre-specified, demonstrated statistically significant improvements in the following endpoints:
Primary unassisted patency over more than three years of follow-up
Secondary patency (AVF survival) over more than three years of follow-up
AVF maturation at 12 weeks
The rate of corrective procedures over more than three years of follow-up
Patients who received vonapanitase reported adverse events related to the AVF comparable to placebo over more than three years of follow-up. These events were consistent with the medical events experienced by CKD patients undergoing surgical creation of an arteriovenous fistula.
Additional Potential Applications in Hemodialysis Vascular Access
Proteon completed a multicenter, randomized, double-blind, placebo-controlled Phase 1/2 clinical trial in patients undergoing surgical creation of an arteriovenous graft (AVG), which is a synthetic tube that connects a vein to an artery. An AVG is considered an alternative form of vascular access for hemodialysis patients who are poor candidates for an AVF.
Patients receiving investigational vonapanitase experienced a non-statistically significant trend toward prolonged secondary patency (AVG survival), and fewer corrective procedures to restore or maintain patency. Patients who received vonapanitase reported adverse events related to the arteriovenous fistula comparable to placebo. Proteon may conduct additional studies of vonapanitase in AVGs.