NovaBay® Pharmaceuticals, Inc. (NYSE-AMEX: NBY, http://www.novabaypharma.com), a clinical stage company developing novel anti-infective compounds for the treatment or prevention of a wide range of bacterial, viral and fungal infections, announced today the start of a Phase 2a proof-of-concept study of its lead Aganocide® compound NVC-422 in impetigo.
NovaBay’s partner in the impetigo trial is Galderma, S.A. the world’s leading dermatology company. NovaBay also is currently engaged in clinical studies of NVC-422 for viral conjunctivitis with its other major partner Alcon (NYSE:ACL), the world’s leading eye care company.
This double-blind, randomized, sequential group study will evaluate the safety and efficacy of a dermal formulation of NVC-422 in 120 patients ages 2 to 12 at two experienced clinical centers in the Dominican Republic. Over 15 patients have been enrolled so far and final results are expected in the first half of 2010.
Impetigo is one of the most common bacterial skin infections affecting over one million people in the US alone, primarily infants and children between the ages of two and six.1 Impetigo usually starts with direct bacterial invasion of healthy skin or when bacteria enter a break in the skin, such as a cut, scratch or insect bite. Symptoms begin with red or pimple-like sores surrounded by red skin. These sores usually occur on the face, arms and legs and fill with pus, then break open after a few days and form a thick crust. Impetigo can spread by contact with sores or nasal discharge from an infected person.2
“Currently impetigo is treated with antibiotic ointments, to which bacteria develop resistance in the same way as to oral antibiotics. An effective alternative treatment for such a common skin disease could significantly reduce our over-reliance on antibiotics and help stop the global spread of drug-resistant bacteria,” said Ron Najafi, Ph.D., Chairman and Chief Executive Officer, NovaBay. “Our goal at NovaBay is to make the need for all topical antibiotics obsolete with our Aganocide compounds, which have no known mechanism for inducing microbial resistance.”
Impetigo is primarily caused by Staphylococcus aureus and Streptococcus pyogenes. The skin condition typically is not life-threatening, but sometimes it may lead to serious complications, including3:
Methicillin-resistant Staphylococcus aureus (MRSA) infection, which can cause serious skin infections that are extremely difficult to treat.
Post-streptococcal glomerulonephritis, which is a kidney inflammation that may lead to chronic kidney failure.
Cellulitis, which is a potentially serious infection that affects the tissues underlying the skin and eventually may spread to the lymph nodes and into the bloodstream.
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 be able to 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 multi-drug resistant strains, 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.
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 dermatological, 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 Pharmaceuticals Contacts
Thomas J. Paulson
Chief Financial Officer
Contact Thomas Paulson