NovaBay Pharmaceuticals completes enrollment in Phase 2a trial of NVC-422 for treatment of impetigo

May 25 2010

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, today announced the completion of enrollment in a Phase 2a proof-of-concept trial for the treatment of impetigo. Impetigo is a highly contagious skin infection afflicting more than 1 million people annually in the United States, primarily children and infants.

The double-blind, randomized, sequential group study evaluated the safety and efficacy of NovaBay's lead Aganocide^® compound, NVC-422, in 120 patients ages 2 to 12 at clinical centers in the Dominican Republic. Preliminary results of the trial will be released in July. NovaBay's partner in the trial is Galderma S.A., one of the world's leading dermatology companies.

NovaBay's effort to develop a new anti-infective treatment for impetigo comes at a time when infections are becoming increasingly resistant to currently available antibiotics. Impetigo is primarily caused by Streptococcus pyogenes or Staphylococcus aureus (staph). However, community-acquired staph skin infections such as impetigo are increasingly caused by methicillin-resistant Staphylococcus aureus (MRSA).

MRSA infections are resistant to certain antibiotics and can be difficult to treat. Complications resulting from impetigo, although rare, include cellulitis and abscesses, deeper soft tissue infections that can spread into the bloodstream. When these infections are caused by community-acquired MRSA, they can be potentially life-threatening and often require systemic (intravenous) antibiotic treatment.

Impetigo is currently treated with topical antibiotic ointments such as Bactroban™ (mupirocin) or Altabax™ (retapamulin), and with oral antibiotics when topical treatments fail or in cases of larger areas of skin infection. Unfortunately, bacteria have developed resistance to some topical antibiotics in the same way they have to some oral antibiotics. For example, mupirocin resistance has been identified on the epidemic community-acquired MRSA strain USA300, suggesting that mupirocin use may select for more resistant strains. The oral treatment options for community-acquired MRSA skin infections are unfortunately very limited and some strains are now resistant to all but a few antibiotics.

NovaBay's Aganocide compounds are novel, synthetic N-chlorinated antimicrobial molecules specifically designed and developed to mimic the body's natural defense against infection. The Aganocide compounds maintain biological activities while demonstrating improved stability over the naturally occurring N-chlorinated antimicrobial molecules. In preclinical testing, NovaBay's Aganocide compounds have been shown to be highly effective against bacteria, including some multi-drug resistant strains (such as MRSA), viruses and fungi. NovaBay's Aganocide compounds have the potential to deliver the same or better efficacy than antibiotics, and to address the growing problem of antibiotic resistance by employing a novel mechanism of action.