Proteon Therapeutics, a clinical-stage company focused on first-in-class therapeutics that meaningfully improve the lives of patients with kidney and vascular diseases has filed for a $50 million offering. The company trades on NASDAQ under the symbol “PRTO.”
Proteon's lead candidate, vonapanitase, is a recombinant human elastase that is being developed for a number of uses. Proteon's most advanced development program is for vonapanitase use to improve vascular access outcomes in patients with chronic kidney disease, or CKD, undergoing or planning for hemodialysis. The company believes data from our completed Ph II and Ph III clinical trials of vonapanitase support that a one-time, local application of investigational vonapanitase during surgical creation of a radiocephalic fistula for hemodialysis may improve fistula use for hemodialysis and secondary patency (time to fistula abandonment),
The drug did not meet its primary endpoint of improved primary unassisted patency, compared to placebo (p=0.254) in its initial Ph III trial. However, for its pre-specified secondary endpoint, the trial showed a 34% reduction in the risk of secondary patency loss over one year, compared to placebo (p=0.048). Additionally, the trial showed a 45% relative increase in fistula use for hemodialysis, compared to placebo (p=0.006), which was another pre-specified endpoint.
The company is expected to announce initial results for its second Ph III trial this month. Vonapanitase received Breakthrough Therapy designation from the FDA in May 2017 for hemodialysis vascular access indications. Vonapanitase previously received Fast Track designation from the FDA and has received orphan drug designations in the United States and European Union for hemodialysis vascular access indications.