Deadly methicillin-resistant Staphylococcus aureus - MRSA - a bacterium that responds poorly to conventional antibiotic treatment, infects 90,000 Americans per year and causes 19,000 deaths, most in hospital settings.
Infections have recently been reported outside of hospital settings at an increasing rate, which has alarmed public health officials. Approximately 14% of MRSA-related illnesses occur in community settings.
While the infection and mortality figures for S. aureus are frightening, the “bug” is a lot more prevalent that one would think. S. aureus colonizes, without infecting, about 30% of human beings. S. aureus colonization exists unnoticed, primarily in the nose and on the skin. Individuals who suffer wounds, or whose immune systems are compromised by illness, are susceptible to conditions as mild as a boil or as life-threatening as systemic infection.
Emeryville, California-based NovaBay Pharmaceuticals, Inc. has announced results from a Phase I clinical trial with NVC-422, a new compound with potent activity against numerous pathogens, including MRSA. NVC-422, whose trade name is AgaNase™, is unique in that it is an anti-infective, but technically not an antibiotic.
Nasal colonization by Staphylococci is an important risk factor that predisposes carriers to nosocomial (hospital) infections. NovaBay hopes that by greatly reducing this layer of colonizing bacteria, hospital patients will be less likely to experience serious MRSA infections.
NVC-422 rapidly destroys a range of pathogens that includes Gram-positive and Gram-negative bacteria, yeasts, and viruses. Because it kills pathogens on contact and not through typical antibiotic mechanisms, it is believed that bacteria and viruses are unlikely to develop resistance to NVC-422 treatment. This “non-antibiotic” strategy is critical for maintaining the efficacy of antibiotic therapies for life-threatening infections.
The recently completed Phase I trial demonstrated that topical application of NVC-422 to the lower nasal passages, or nostrils, is safe and well tolerated. Moreover, researchers could not detect any trace of NVC-422 in the blood.
The clinical study tested safety and tolerability following repeated applications of AgaNase at two drug concentrations, 0.1% and 0.3%, applied by spray or swab to the nostrils. Ninety-six subjects were enrolled and completed the study. Adverse events were local, mild and transitory and did not appear to increase with dosage.