NovaBay Pharmaceuticals, Inc. (NYSE-Amex: NBY) today 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.
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