Proteon Therapeutics announced that FDA has awarded Breakthrough Therapy Designation to vonapanitase (investigational treatment) for increasing arteriovenous fistula secondary patency and use for hemodialysis in patients on or expected to initiate hemodialysis.
Proteon’s Breakthrough Therapy designation is supported by data from PATENCY-1, the Company’s first Phase 3 clinical trial evaluating vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula. In that study, vonapanitase demonstrated clinically meaningful improvements in secondary patency and use for hemodialysis, although it did not meet the primary endpoint of improving primary patency.
Proteon Therapeutics President and CEO, Timothy Noyes said that they believe the decision by the FDA to grant vonapanitase a Breakthrough Therapy designation speaks to the clinical importance of fistula survival and use for hemodialysis to patients with chronic kidney disease. Their productive ongoing dialogue with the FDA has helped to create a clear path forward for vonapanitase, and they look forward to continuing to work closely with the FDA to expedite their development efforts for this important program.
Enrollment in the PATENCY-2 trial is expected to complete in the first quarter of 2018 and Proteon expects to report top-line data in the first quarter of 2019. Proteon also expects to submit a BLA to the FDA in 2019.