NovaBay's Aganocides Show Penetration And Efficacy In A Pre-Clinical Infected Human Nail Model Of Onychomycosis

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Dermatology;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 31 Oct 2009 - 1:00 PDT

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NovaBay Pharmaceuticals, Inc. (NYSE-Amex: NBY) announced that its Aganocide® compounds demonstrate potent antifungal activity in an established pre-clinical infected nail model of onychomycosis. The study data will be presented tomorrow at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Philadelphia.

"This model tests both the penetration of the nail as well as the effectiveness of the compounds against the targeted fungus. What is remarkable is that, after treatment, the Aganocide formulations were able to eradicate the fungi grown on the other side of the nail, hence indicating not only good penetration but a good antifungal activity against T. rubrum, the fungus responsible for onychomycosis commonly known as nail infection," said Dr. Behzad Khosrovi, senior vice president of product development at NovaBay. "Nail fungus is notoriously difficult to treat predominantly due to the inability of many topical antifungal drugs to penetrate the nail, a hurdle we were able to overcome due to the proprietary characteristics of our compounds."

The study "In Vitro Evaluation of Stable Derivatives of the Chlorotaurines( )on Infected Human Nail Model as Potent Antifungal Agents for the Treatment of Onychomycosis" tested formulations of both N,N-dichloro-2,2-dimethyltaurine (NVC-422) and N-chloro-2,2-dimethyltaurine (NVC-612), both proprietary NovaBay compounds, which are stable derivatives of endogenous chlorotaurines that possess potent and rapid antimicrobial activity against a wide range of pathogens. The endogenous chlorotaurines play an important role in mammalian innate immunity to invading pathogens.

"Onychomycosis represents a significant market opportunity for any topical agent," said Ron Najafi, Ph.D., chairman and chief executive officer of NovaBay. "We are encouraged by these preclinical results, especially given the rigor of the MedPharm model and its established and predictive value."

In this model, developed and conducted by MedPharm LTD, Surrey, United Kingdom, formulations of both NVC-422 and NVC-612 were highly effective against Trichophyton rubrum, the fungus commonly found in nail infections and normally very difficult to eradicate. A laboratory-cultured clinical isolate of T. rubrum was used to infect full thickness sterile human nails in specially constructed cells. After 14-days of incubation, single applications of the Aganocide formulations were applied to the nail surface opposite from the infected side. After seven more days of incubation, the nails were analyzed for the presence of adenosine triphosphate (ATP) as a measure of fungal viability. Uninfected nails, infected untreated nails and placebo treated nails were used as controls.

About Onychomycosis

Onychomycosis is the infection of the nail plate/bed by a fungus. Although onychomycosis is considered a cosmetic condition, it can cause acute pain while the physical manifestations of the infection often have adverse social and occupational ramifications for affected patients. As such, onychomycosis is an infection that warrants an effective medical treatment. According to Podiatry Today, over 35 million people in the United States have onychomycosis. Estimates indicate that up to 50% of those affected by the disease do not receive treatment. Systemic treatments represent well over 80% of the market today, but have potential severe liver toxicity issues, and have shown to have relapse rates of 40% or higher.

About Aganocide Compounds

The Aganocide compounds are novel, proprietary, synthetic N-chlorinated antimicrobial molecules specifically developed by NovaBay to mimic the body's natural defense against infection. The Aganocide compounds maintain the biological activities while improving the stability of naturally occurring N-chlorinated antimicrobial molecules. These highly differentiated, first-in-class, small molecule, patented new chemical entities may deliver the same or better efficacy than currently used antibiotics without contributing to the growing rise of antibiotic-resistant bacterial strains. In preclinical testing, the Aganocide compounds have been shown to be highly effective against bacteria, including its multi-drug resistant strains (such as MRSA), viruses and fungi. They also have been demonstrated to be effective against bacteria in biofilms, which render most antibiotics ineffective. Aganocides have a broad therapeutic index while providing a high degree of potency and tolerability as well as dosing versatility and flexibility.

About NovaBay

NovaBay Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing its proprietary and patented Aganocide compounds, which are novel, synthetic anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells to treat and prevent a wide range of infections without causing bacterial resistance. NovaBay has internal development programs aimed at addressing hospital and respiratory infections. The company has a licensing and research collaboration agreement with Alcon, Inc. for use of its Aganocide compounds to treat eye, ear and sinus infections as well as in contact lens care solutions. NovaBay has also entered into an agreement with Galderma S.A. to develop and commercialize Aganocides in acne, impetigo and other dermatological indications. NovaBay(TM) and Aganocide® are trademarks of NovaBay Pharmaceuticals, Inc.

Cautionary Information Regarding Forward-Looking Statements

The statements in this press release regarding NovaBay's expectations of the potential for its product candidates to address onychomycosis, the market opportunity for onychomycosis, and the potential benefits of NovaBay's Aganocide products, are forward-looking statements subject to risks and uncertainties. Actual results may be different than those NovaBay expects due to a number of factors, including the risk that results in pre-clinical trials will not be replicated in clinical trials, and other risks relating to NovaBay and its Aganocide compounds, detailed in NovaBay's Quarterly Report on Form 10-Q, under the caption "Risk Factors" in Item 1A of Part II of that report, which was filed with the Securities and Exchange Commission on August 14, 2009.

Source: NovaBay Pharmaceuticals, Inc