November 4, 2015 – NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a biopharmaceutical company focusing on commercializing and developing non-antibiotic antimicrobial products for the global eye care market, announces plans to report results from a clinical study with its proprietary anti-microbial compound auriclosene (NVC-422) to reduce urinary catheter blockage and encrustation in patients with long-term indwelling urinary catheters in early December.
Due to spinal cord injuries, multiple sclerosis, strokes or other neurogenic bladder conditions, an estimated 100,000 patients in the U.S. have indwelling catheters and episodically suffer from blockage and encrustation. In these patients catheters repeatedly become coated with bacteria and bacterial biofilm, which may produce localized crystal deposits that may build up and block the catheter. The severe consequences of urinary catheter blockage and encrustation are often underappreciated. Catheter blockage can result in urinary tract infections, socially embarrassing urine leakage around the catheter, and frequent use of emergency services. In those with high-level spinal cord injuries, potentially life-threatening autonomic dysreflexia can occur.
“In September 2014 we initiated a two-arm, parallel-design study comparing Auriclosene Irrigation Solution (AIS) to its vehicle,” said NovaBay President and CEO Ron Najafi. “This followed positive results of an earlier Phase 2 cross-over design study for the treatment of urinary catheter blockage and encrustation in which AIS was compared to saline solution, the standard of care. However, early in 2015 we refocused NovaBay’s commercial strategy with the launch of our proprietary Avenova™ Daily Lid and Lash Hygiene product as our top priority with an eye toward monetizing other assets in our pipeline. We decided to move forward with the evaluation of data from the group of patients enrolled to date in this clinical trial as we believe that auriclosene has significant potential in this indication. The results, if positive, could improve the value at which we monetize this auriclosene asset.”
The study results will include data from 34 evaluable subjects with indwelling urinary catheters randomized into two equal arms. Subjects received irrigations of AIS or its vehicle administered two times a week for four weeks. The objectives of this study are to evaluate catheter flow rate reduction, early removal of catheters due to clinical blockage as well as safety and tolerability of AIS.
In September 2013 NovaBay announced highly statistically significant benefit of AIS compared with saline in the earlier Phase 2, double blind, randomized, cross-over designed study. In this study catheters of the subjects were irrigated twice weekly with a solution of either AIS or saline for a total of eight treatments over four weeks, followed by a washout period and a similar cross-over treatment. For the 14 subjects completing this study AIS significantly reduced encrustation and blockage (p<0.001). There were no cases of blockage in the AIS treated group whereas blockage occurred in the majority of the saline treated group. No significant safety or tolerability issues were identified.
About Auriclosene (NVC-422)
Auriclosene is NovaBay’s lead Aganocide compound. These compounds work by mimicking the body’s natural defense against infection. Since the body’s immune system works without ever creating resistance, NovaBay has taken the effective and rapidly acting molecules that function within our own bodies and created stable analogs of these molecules. The Company’s compounds have shown to be fast-acting with broad spectrum activity, effective against multi-drug resistant bacteria and biofilm, and with a good safety profile.
About Urinary Catheter Blockage and Encrustation
Blockage and encrustation of indwelling catheters results from the build-up of calcium and magnesium crystals in the lumen and inlet of catheters, which is caused by gram-negative bacteria. The condition requires catheters to be changed frequently. It can also lead to urinary tract infections, kidney infections and incontinence due to the leakage of urine around the outside of clogged catheters. In certain patients, severe and life-threatening episodes of uncontrolled autonomic dysreflexia can occur. Autonomic dysreflexia is an involuntary nervous system reaction to noxious stimuli that can lead to a sudden, severe increase in blood pressure. The most frequent causes of autonomic dysreflexia in those with an indwelling catheter are bladder over distention and catheter blockage. The autonomic dysreflexia continues until the blocked catheter is changed. If blockage is not dealt with immediately, the increased blood pressure could lead to a life-threatening stroke or cardiovascular event.
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics
NovaBay Pharmaceuticals is a biopharmaceutical company focusing on commercializing and developing its non-antibiotic anti-infective products to address the unmet therapeutic needs of the global, topical eye care market with its two distinct product categories: the NEUTROX™ Family of Products, cleared by the US FDA as a 510(k) medical device; the NEUTROX™ Family of Products includes AVENOVA™ for the eye care market and NEUTROPHASE® for wound care, and CELLERX™ for the cosmetic surgery and aesthetic dermatology market; and its AGANOCIDE® compounds, led by AURICLOSENE™ which is in development as a new drug in urology and dermatology.
NovaBay has partnerships in the U.S. and around the world with PBE, Inc. (U.S.), IHT, Inc. (U.S.), Galderma (France), Virbac (France), China Pioneer Pharma (China and Southeast Asia), Shin Poong Pharmaceuticals (South Korea), Biopharm (North African and the Middle East), Sarmedic Ltd (Israel), Ophthalmic Instrument Company (New Zealand) and Alpha Pharma LLC (the Ukraine).
In June 2015, NovaBay announced FDA clearance of intelli-Case™, an innovative, easy-to-use device for safely disinfecting soft and rigid gas permeable (RGP) contact lenses with hydrogen peroxide.
Safe Harbor / Forward-Looking Statements
This release contains forward-looking statements, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to potential of NVC-422 to treat urinary catheter blockage and encrustation, market acceptance of auriclosene, and our ability to find a viable partner for this program. Other risks relating to NovaBay and its products, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s latest Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading “Risk Factors.” The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.
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From the Company
Thomas J. Paulson
Chief Financial Officer
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Partner with NovaBay
Roy J. Wu
SVP Business Development
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