Proteon Therapeutics, Inc. (PRTO)

[fredman]

Proteon CEO: New trial could be a path to market
Mar 17, 2017, 8:01am CDT

After Proteon Therapeutics Inc.'s chronic kidney disease treatment failed a late clinical trial, the company is forging forward with a new plan that could take the drug to market.

The Waltham, Mass.-based company's treatment, vonapanitase, was originally developed by Kansas City entrepreneur Nick Franano. It's intended to help maintain blood flow through an arteriovenous fistula (AVF), a connection between an artery and a vein, used for patients on dialysis.

CEO Tim Noyes says Proteon Therapeutics Inc. has a new approach to taking its vonapanitase treatment to market.

CEO Tim Noyes says Proteon Therapeutics Inc. has a new approach to taking its… more

"What we're trying to do is not just improve outcomes but give patients an improvement that is durable and lasting," Proteon CEO Tim Noyes said. "This is a problem that really does cause a group of patients a great health burden and increases their mortality."

A December double-blind study of vonapanitase showed it reduced the risk of fistula blockage by 17 percent compared with a placebo, not a statistically significant difference. The company's stock dropped from $9.90 to $2.90 after the day the results were revealed. Three months later, the stock closed Thursday at $1.75.

There was a silver lining in the results: the initial study showed the drug reduced fistula abandonment by 36 percent. By using a fistula for dialysis, patients can avoid access via a catheter, which can lead to infection and other complications.

A new clinical trial will focus primarily on the drug's ability to prevent fistula abandonment. Instead of conducting a trial of 300 patients, Proteon (Nasdaq: PRTO) hopes to enroll 500 before the end of 2017.

The new stage-three trial, called "Patency 2," includes another important feature: a regulatory agreement with the FDA stating if the trial is successful, Proteon could take one step closer to commercialization.

"If Patency 2 is successful, it would serve as a basis for filing a (Biologics License Application)," Noyes said. "… We would file the BLA and hope that is sufficient for approval to start commercialization."

If the study goes well, Noyes said the company would submit an application in 2019. With the needed approvals, Proteon would hire its own salesforce and launch the treatment in the U.S.

"The company got started not only because of (Franano), but all of the support from angel investors in Kansas City," he said. "We certainly hope to be one of the great success stories that was developed in Kansas City."

Source: http://www.bizjournals.com/kansascity/news/2017/03/17/proteon-therapeutics-vonapanitase-new-stage3-trial.html