NovaBay Pharmaceuticals, Inc. (NYSE Amex:NBY), a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, delivered two poster presentations on its compounds at the 48th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Vancouver, Canada.
The presentations included new data from clinical and preclinical studies of NovaBay's Aganocide® compounds, which have shown to be highly effective against bacteria, including some multi-drug resistant strains (such as MRSA), viruses and fungi in preclinical testing.
Ron Najafi, Chairman and CEO of NovaBay, said, "These presentations illustrated compelling clinical evidence of effectiveness in the treatment of impetigo and preclinical effectiveness for the treatment of nail fungus infection. The versatility and power of these compounds have been vividly demonstrated as a result."
NovaBay's pipeline of Aganocide compounds is being studied in numerous preclinical and clinical programs. Three clinical programs of the company's lead Aganocide drug candidate are under way for the treatment of impetigo, a highly contagious skin infection; urinary catheter encrustation and blockage; and conjunctivitis, or pink eye.
The posters and their conclusions were as follows:
"A Pilot Study to Evaluate the Safety and Efficacy of NVC-422 Topical Gel in Impetigo, Including MRSA"
Impetigo is a highly contagious superficial bacterial infection of the skin that affects mostly children. Most cases are caused by Staphylococcus aureus, Streptococcus pyogenes, or a mixture of both organisms. Methicillin-resistant S. aureus (MRSA) is being observed with increasing frequency in this population. Impetigo is currently being treated with antibiotic ointments, to which bacteria may develop resistance.
This randomized, sequential group, double-blind study was designed to evaluate the efficacy and safety of three different strengths of NVC-422 Topical Gel in the treatment of impetigo. A total of 129 children in the age range 2-12 presenting with impetigo were randomized for treatment with NVC-422 topical gel three times daily for 7 days. Efficacy evaluations, compared to baseline, were conducted at the end of treatment and one week later. Clinical and bacteriological response rates for the three concentrations of drug applied ranged from 84% to 95% at end of treatment and at follow up. These response rates were substantially higher than the response rate anticipated for placebo (30-50%). Notably, response rates for MRSA infections were 100% (10/10) across all treatment groups. The clinical and bacteriological response rates across the treatment groups suggested a dose response, although differences were not statistically significant. Infrequent adverse events were mild to moderate in severity and were predominantly local reactions at the application site. All adverse events resolved after the end of treatment.
This proof of concept study provided compelling evidence of the activity of NVC-422 topical gel in the treatment of impetigo.
"In Vitro Evaluation of the Antifungal Activity of NVC-422 (N,N-dichloro-2,2-dimethyltaurine) using a Novel Cadaver Nail Model"
Onychomycosis is the most commonly diagnosed nail disorder. Topical treatment of the infection is limited by the inability of currently available drugs to penetrate the human nail. NovaBay's lead Aganocide compound, NVC-422 is a hydrophilic agent with potent antimicrobial activity making it a good candidate to be evaluated in a human clinical trial.
NovaBay has used other validated in vitro models and presented the results during the 47th IDSA annual meeting in 2009 ("In Vitro Evaluation of Stable Derivatives of the Chlorotaurines on Infected Human Nail Model as Potent Antifungal Agents for the Treatment") conducted by MedPharm Ltd.
This new study was conducted using a novel in vitro infected human nail model to evaluate and confirm the ability of novel NVC-422 gel formulations and nanoemulsion lacquers to penetrate and kill fungi grown on the subungal side of the infected nail. The study was conducted at University Hospitals Case Medical Center, Center for Medical Mycology, Cleveland, OH, USA.
These most recent data showed that NVC-422 was able to penetrate the nail and effectively eradicate T. mentagrophytes and T. rubrum. The study also confirmed our earlier studies using a completely different approach. Further evaluation of NVC-422 is warranted.