NovaBay® Pharmaceuticals, Inc. (NYSE AMEX:NBY), a biotech company developing novel anti-infective products for the treatment and prevention of topical infections including those caused by antibiotic-resistant bacterial strains, announced today the publication of key data demonstrating that development of resistance to NovaBay’s lead Aganocide compound, NVC-422, is highly unlikely for a variety of infectious organisms, including methicillin-resistant S. aureus (commonly known as MRSA), compared to traditional antibiotics. Study results were published in the May 2012 issue of Antimicrobial Agents and Chemotherapy1, the journal for the American Society for Microbiology.
NovaBay is developing NVC-422, a novel anti-infective with broad-spectrum bactericidal activity and novel mechanism of action to address the unmet medical needs in several large markets. Different topical formulations of NVC-422 are in mid-to-late-stage clinical development in ophthalmology, dermatology and urology.
“Despite worldwide efforts, the battle against antibiotic resistance continues. With microbial evolution outpacing human invention, there is a growing need for truly novel compounds,” commented Dr. Richard Odom, Sonoma Dermatology, Sonoma, Calif., and past president of the American Academy of Dermatology. “This is a seminal article for those in the industry of infectious diseases, as it confirms the potency of NVC-422 against potentially deadly bacteria, and shows the bacteria’s low likelihood to develop resistance to NVC-422. As a practicing dermatologist, I believe a new topical agent of this nature would be a welcomed addition to our treatment options, particularly in highly drug-resistant infections such as caused by MRSA.”
In the study, NVC-422 was tested for development of resistance in strains of E. coli, P. aeruginosa, and S. aureus, including MRSA. The study used a well-recognized serial passage model to determine if the bacteria are likely to develop resistance over time. Compared to antibiotics currently used today, NVC-422 was the only antimicrobial agent tested to which bacterial susceptibility remained unchanged for up to 50 passages, indicating that the bacteria did not become resistant. In fact, over the course of the entire study, there was no significant increase in the minimum inhibitory concentration2 (MIC) for NVC-422 against any of the organisms tested.
“Passage studies are important predictors for the development of drug resistance. Our Aganocide compounds kill bacteria by inactivating proteins on the bacterial cell surface, resulting in a low probability of resistance development,” explained Dr. Dmitri Debabov, senior author and Head of Microbiology and Cell Biology at NovaBay. “This study not only showcases NVC-422 as an antimicrobial agent that has a strong potential of being ‘immune’ to resistance, it also highlights the inadequacies of current antibiotics because bacteria can rapidly become resistant, especially when antibiotics are used at sub-lethal concentrations.”
In stark contrast to NVC-422, MICs for the broad-spectrum antibiotic comparator, ciprofloxacin, increased over 250-fold for E. coli and over 30-fold for both P. aeruginosa and S. aureus after 25 serial passages. For highly drug-resistant MRSA, MICs for currently used topical antibiotics mupirocin, fusidic acid, and retapamulin increased 64-, 256-, and 16-fold, respectively, after 50 serial passages. Importantly, strains that developed resistance to these antibiotics were still killed by the same concentration of NVC-422 as killed the original susceptible strains, highlighting the potential benefit of this novel class of anti-infectives in fighting the spread of resistant pathogens.
For more information about NovaBay’s novel, anti-infective Aganocide compounds, please visit www.novabaypharma.com.
D’Lima L, Freiman L, Wang L, Xu P, Anderson M, Debabov D (2012) No Decrease in Susceptibility to NVC-422 in Multiple-Passage Studies with Methicillin-Resistant Staphylococcus aureus, S. aureus, Pseudomonas aeruginosa, and Escherichia coli. Antimicrob. Agents Chemother. May 2012 vol. 56 no. 5 p. 2753-27552 The amount of drug necessary to inhibit visible growth of cultured bacteria
About NovaBay Pharmaceuticals, Inc.
Going Beyond Antibiotics
NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with its two distinct categories of products.
NovaBay’s first-in-class Aganocide compounds, led by NVC-422, are patented, synthetic molecules with a broad spectrum of activity against bacteria, viruses and fungi. Mimicking the mechanism of action that human white blood cells use against infections, Aganocides possess a reduced likelihood that bacteria or viruses will be able to develop resistance, which is critical for advanced anti-infectives. Having demonstrated therapeutic proof-of-concept in Phase 2 clinical studies, these compounds are suited to treat and prevent a wide range of local, non-systemic infections. NovaBay is currently concentrated on three large therapeutic markets:
Dermatology – Partnered with Galderma, a leading dermatology company, to develop a formulation of NVC-422 for treatment of highly contagious skin infection, impetigo. Current product offerings give rise to resistance. A major global clinical study is planned for 2012.
Ophthalmology – NovaBay is developing an eye drop formulation of NVC-422 for treating adenoviral conjunctivitis, for which there is currently no FDA-approved treatment. The Company expects to launch a global Phase 2b clinical study in this indication in the second quarter of 2012.
Urology – NovaBay’s urinary catheter irrigation solution containing NVC-422 is currently in Phase 2 clinical studies, with the goal of reducing the incidence of urinary catheter blockage and encrustation (UCBE) and associated urinary tract infections. The Company reported positive data from Part A of this study and expects to announce top-line results from Part B in the second half of 2012.
NovaBay is also developing NeutroPhase, which is an FDA 510(k)-cleared product for advanced wound care. We believe that NeutroPhase is the only patented pure hypochlorous acid solution available and has the potential to be best suited to treat the six-million-patients in the U.S. who suffer from chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers.
For additional information, visit: www.novabaypharma.com
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Forward Looking Statements
This release contains forward-looking statements, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. Statements regarding NovaBay’s expectations including, but not limited to, (i) any potential plans for future clinical development of its Aganocide compounds and of bringing products to market including the expected timing of the initiation of the Phase 2b impetigo clinical trial and Phase 2 conjunctivitis trial and expected timing of the results of the Phase 2, Part B UCBE trial; (ii) the potential efficacy of Aganocide compounds; (iii) the development and potential benefits of, and the market opportunities for, NovaBay’s product candidates (iv) the potential to deliver the same or better efficacy than antibiotics and to address the growing problem of antibiotic resistance as well as other statements that relate to future events or results, are forward-looking. 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: inherent risks and uncertainties relating to difficulties or delays in conducting clinical trials; the inherent uncertainty of patent protection for the company’s intellectual property or trade secrets, risks and uncertainties relating to difficulties or delays in discovery, development, testing, production and marketing of the company’s product candidates; unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates; the company’s ability to obtain additional financing as necessary; and the risk of unexpected delays in the regulatory process which may delay the commencement or completion of clinical trials. Other risks relating to NovaBay and Aganocide compounds, 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 Annual Report on Form 10-K for the period ended December 31, 2011, under the caption “Risk Factors” in Item 1A of Part I of that report, filed with the Securities and Exchange Commission on March 27, 2012. 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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