Proteon Therapeutics Completes Enrollment in PATENCY-2, Phase 3 Clinical Trial of Investigational Vonapanitase
PATENCY-2 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial in patients with chronic kidney disease (CKD) receiving or expecting to receive hemodialysis and undergoing surgical creation of a radiocephalic arteriovenous fistula. The trial is designed to evaluate, over one year, whether a single administration of 30 micrograms of vonapanitase can improve radiocephalic fistula use for hemodialysis and secondary patency, the trial’s co-primary endpoints. Secondary patency is defined as the length of time from surgical creation until fistula abandonment (final failure).
“We are excited to have completed enrollment in the second Phase 3 trial of vonapanitase, a significant achievement for Proteon and for the dialysis community,” said
The trial treated 603 patients at 39 centers across
PATENCY-2 is the fourth multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating vonapanitase in patients with CKD receiving or expecting to receive hemodialysis and undergoing surgical creation of an arteriovenous fistula. Combined, these studies have enrolled more than 1,100 CKD patients at 62 centers in
About Chronic Kidney Disease, Hemodialysis and Vascular Access
In the most severe stage of chronic kidney disease (CKD), also known as kidney failure, the kidneys can no longer function to sustain life. The majority of patients with kidney failure undergo chronic hemodialysis, which requires a high-flow vascular access to repeatedly connect the patient's bloodstream to a hemodialysis machine for this life-saving treatment. The preferred form of vascular access for hemodialysis is a radiocephalic arteriovenous fistula, created when a surgeon connects a vein to an artery in the lower arm, resulting in a substantial increase in blood flow and vein dilation.
Vonapanitase is an investigational drug intended to improve hemodialysis vascular access outcomes. Vonapanitase is applied in a single administration and is currently being studied in a Phase 3 clinical trial in patients with CKD undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. Vonapanitase has received Breakthrough Therapy, Fast Track and Orphan Drug designations from the FDA, and Orphan Medicinal Product designation from the European Commission, for hemodialysis vascular access indications. In addition, vonapanitase may have other surgical and endovascular applications in diseases or conditions in which vessel injury leads to blockages in blood vessels and reduced blood flow. Proteon is currently conducting a Phase 1 clinical trial of vonapanitase in patients with peripheral artery disease (PAD).
Proteon Therapeutics is committed to improving the health of patients with kidney and vascular diseases through the development of novel, first-in-class therapeutics. Proteon's lead product candidate, vonapanitase, is an investigational drug intended to improve hemodialysis vascular access outcomes. Proteon is evaluating vonapanitase in patients with CKD undergoing surgical creation of a radiocephalic arteriovenous fistula. Proteon is also evaluating vonapanitase in a Phase 1 clinical trial in patients with PAD. For more information, please visit www.proteontx.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are, or may be deemed to be, "forward-looking statements." In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “estimates,” “anticipates,” "expects,” “plans,” "intends,” “may,” or “will,” in each case, their negatives or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements, including when the Company expects to report top-line data from the PATENCY-2 trial, whether the PATENCY-2 trial will serve as a single pivotal trial or additional studies will be necessary to support a BLA submission, whether and when we may submit a BLA in the
George Eldridge, Proteon Therapeutics, Senior Vice President and Chief Financial Officer
Ann Stanesa, Ten Bridge Communications
Source: Proteon Therapeutics, Inc.