We have completed clinical trials with vonapanitase in multiple potential indications.
Arteriovenous Fistula Outcomes for Hemodialysis Patients
We have completed the first of two Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trials in patients undergoing surgical creation of an radiocephalic fistula for hemodialysis.
PATENCY-1, the first Phase 3 clinical trial, evaluated the safety and efficacy of a single 30 mcg application of investigational vonapanitase compared to placebo in 313 patients undergoing surgical creation of a radiocephalic arteriovenous fistula.
The trial’s primary endpoint, primary unassisted patency, was the length of time from fistula creation to the first occurrence of a fistula thrombosis or corrective procedure to restore or maintain patency (blood flow). Vonapanitase-treated patients demonstrated a non-statistically significant 17% reduction in the risk of primary unassisted patency loss over one year, compared to placebo (p=0.254).
While this trial did not meet the primary endpoint of improving primary unassisted patency, vonapanitase demonstrated clinically meaningful improvements in other efficacy endpoints, including:
34% reduction in the risk of secondary patency loss (fistula abandonment) over 12 months (p=0.048)
45% relative increase (20% absolute increase) in the proportion of patients who had a fistula that was used for hemodialysis (p=0.006); and
56% relative increase (14% absolute increase) in the proportion of patients who had a fistula that was used for hemodialysis without a prior corrective procedure such as angioplasty (p=0.035)
Adverse events were comparable between vonapanitase and placebo arms of the study. These events were consistent with the medical events experienced by patients with CKD undergoing surgical creation of a radiocephalic fistula.
PATENCY-2, the second Phase 3 multicenter, double-blind, placebo-controlled clinical trial in patients undergoing surgical creation of an arteriovenous fistula for hemodialysis, is continuing to enroll patients.
Additional Potential Applications in Hemodialysis Vascular Access
We 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 arteriovenous graft is considered an alternative form of vascular access for hemodialysis patients who are poor candidates for a fistula.
Patients receiving investigational vonapanitase experienced a non-statistically significant trend toward prolonged secondary patency, and fewer corrective procedures to restore or maintain patency. Patients who received vonapanitase reported adverse events related to the arteriovenous graft comparable to placebo. We may conduct additional studies of vonapanitase in grafts.