Proteon Therapeutics Announces Full-Year 2016 Financial Results and Changes to the Ongoing Phase 3 PATENCY-2 Clinical Trial
- Efficacy endpoints reordered and co-primary endpoints established -
- Ongoing trial, if successful, expected to serve as single pivotal study for BLA submission -
- Conference Call Scheduled for
“The results from PATENCY-1 provided us critical insights into studying vonapanitase that have allowed us to strengthen the PATENCY-2 trial,” said
Clinical Trial Update for PATENCY-2
Important changes to PATENCY-2, the second Phase 3 clinical study of investigational vonapanitase. After announcing top-line results from the first Phase 3 clinical trial, PATENCY-1, in
- The protocol amendment reordered the existing endpoints for the PATENCY-2 trial, establishing secondary patency and fistula use for hemodialysis as co-primary endpoints.
- Secondary patency is defined as the length of time from surgical creation until fistula abandonment (final failure), the same definition used in PATENCY-1 in which secondary patency served as the secondary endpoint. In PATENCY-1, vonapanitase-treated patients experienced a 34% reduction in the risk of secondary patency loss over one year, compared to placebo (p=0.048). At the end of one year, 74% of vonapanitase-treated patients maintained secondary patency, compared to 61% of placebo-treated patients.
- Use for hemodialysis is defined as use of the fistula for hemodialysis for at least 90 days or, if hemodialysis was not initiated at least 90 days prior to the patient’s last visit, for at least 30 days prior to the patient’s last visit and in use at the patient’s last visit. This is the same definition used in PATENCY-1. In PATENCY-1, 64% of vonapanitase-treated patients used their fistula for hemodialysis, compared to 44% of placebo-treated patients (p=0.006), a 45% relative increase.
- The protocol amendment also increased the planned enrollment for this trial from 300 to 500 patients, which provides greater than 90% power to detect the differences observed in the PATENCY-1 trial with a p-value ≤0.05 for each of the co-primary endpoints.
- Based on the Company’s interactions with the
FDA, Proteon believes that, if the PATENCY-2 trial is successful in showing statistical significance (p≤0.05) on each of the co-primary endpoints, the PATENCY-2 trial together with data from previously completed studies would provide the basis for a Biologics License Application, or BLA, submission as a single pivotal study, in which case no additional studies would need to be conducted.
Enrollment continues according to plan in PATENCY-2. PATENCY-2 is a multicenter, randomized, double-blind, placebo-controlled study expected to enroll 500 patients in
Topline clinical results announced in
PATENCY-1 clinical results were presented in
The Company initiated enrollment in a Phase 1 clinical study of vonapanitase in patients with peripheral artery disease (PAD). The multicenter, randomized, double-blind, placebo-controlled Phase 1 dose escalation study is expected to enroll in 2017 up to 24 symptomatic PAD patients being treated with balloon angioplasty of an artery below the knee and to follow each patient for up to seven months. Immediately following successful angioplasty, vonapanitase or placebo is delivered to the arterial wall using the Mercator MedSystems Bullfrog® Micro-Infusion Catheter. The primary outcome measure of the study will be safety and the secondary outcome measure will be technical feasibility of drug delivery via the catheter.
Board of Directors strengthened with the addition of commercial and executive expertise. In the fourth quarter of 2016, the Company appointed
Key Milestones for 2017
- Complete enrollment of 500 patients in PATENCY-2 in the fourth quarter of 2017.
- Enroll 24 patients in the PAD Phase 1 trial before the end of 2017.
- Presentation at the (i) 10th
Congressof the Vascular Access Society April 5-8in Ljubljana, Slovenia(ii) National Kidney Foundation2017 Spring Clinical Meetings April 18-22in Orlando, FLand (iii) The Charing Cross Symposium (CX 2017) April 25-28in London, England.
- Presentations at the (i) Oppenheimer 27th Annual Healthcare Conference
March 21-22in New York City, NY, (ii) Deutsche Bank42nd Annual Health Care Conference May 3-4in Boston, MAand (iii) JMP Securities Life Science Conference June 20-21in New York City, NY.
Full-Year 2016 Financial Results
Cash position: Cash, cash equivalents and available-for-sale investments totaled
R&D expenses: Research and development expenses for 2016 were
G&A expenses: General and administrative expenses for 2016 were
Other expense: Other expense for 2016 was
Net loss: Net loss for 2016 was
Financial guidance: The Company expects that its cash, cash equivalents and available-for-sale investments will be sufficient to fund its operations into the third quarter of 2018.
Conference Call and Webcast regarding Clinical Trial Update for PATENCY-2
Proteon is hosting a webcast and conference call today,
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 program in patients with CKD undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. Vonapanitase has received fast track and orphan drug designations from the
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 the number of patients to be enrolled in and the timing of enrollment in the Company’s ongoing and planned clinical trials of vonapanitase, when the Company expects to report top-line data from the PATENCY-2 trial, whether and when we may submit a BLA in
|Proteon Therapeutics, Inc.|
|Consolidated Balance Sheet Data|
|Cash, cash equivalents and available-for-sale investments||$||41,317||$||65,263|
|Prepaid expenses and other current assets||1,438||1,345|
|Property and equipment, net and other non-current assets||765||930|
|Accounts payable and accrued expenses||$||5,079||$||3,596|
|Common stock and additional paid-in-capital||198,218||194,667|
|Accumulated deficit and accumulated other comprehensive loss||(159,777||)||(131,262||)|
|Total liabilities and stockholders’ deficit||$||43,520||$||67,538|
|Proteon Therapeutics, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Year Ended December 31,|
|Research and development||18,869||12,381||6,432|
|General and administrative||9,836||8,489||4,096|
|Total operating expenses||28,705||20,870||10,528|
|Loss from operations||(28,705||)||(20,870||)||(7,580||)|
|Other income (expense):|
|Interest income (expense)||193||144||(833||)|
|Other (expense) income||(14||)||(651||)||5,071|
|Total other (expense) income||179||(507||)||4,238|
|Net loss per share attributable to common stockholders - basic and diluted||$||(1.72||)||$||(1.30||)||$||(3.16||)|
|Weighted-average common shares outstanding - basic and diluted||16,561,799||16,464,123||3,064,507|
|Supplemental disclosure of stock-based compensation expense and loss from currency forward contracts:|
|Included in operating expenses, above, are the following amounts for non-cash stock based compensation expense:|
|Research and development||$||1,114||$||650||$||114|
|General and administrative||2,229||1,514||345|
|Included in other expense, above, are the following amounts from forward foreign currency contracts:|
|Realized losses from forward foreign currency contracts||$||(61||)||$||(52||)||$||-|
|Unrealized losses from forward foreign currency contracts||127||(537||)||-|