Non-Antibiotic Anti-infective Successful in Phase 2 Skin Infection Trial

NovaBay Pharmaceuticals, Inc. announces that its lead product candidate was safe and efficacious against the highly contagious skin infection impetigo in a Phase 2a proof-of-concept clinical trial. This dose-ranging study showed that the drug cleared impetigo infections, including those in the trial caused by a drug-resistant strain of bacteria called methicillin-resistant Staphylococcus aureus or MRSA. Impetigo afflicts approximately 1 million people, primarily infants and children, in the United States annually.

Robust efficacy was demonstrated in all three doses in this randomized, double-blind, dose-ranging study enrolling 129 patients ages 2 to 12. Clinical response rates at the end of the treatment were 85 percent, 87 percent and 92 percent respectively for the low, medium or high doses. Bacteriological response rates at the end of the treatment were 87 percent, 89 percent and 95 percent for the ascending doses. The response rate for the 10 patients infected with MRSA who completed treatment was 100 percent. These response rates compare favorably to previously published results from studies of topical antibiotics, and are substantially higher than the historical placebo response rates of 30 percent to 50 percent. The results showed a trend towards a dose response, and the treatment was well-tolerated.

The data from this trial is undergoing further analysis and will be submitted to an appropriate scientific conference for presentation.

"This clinical trial is a significant validation of our Aganocide® platform technology, which holds the promise for producing a range of safe, broad-spectrum anti-infectives that would be unlikely to cause drug resistance," said CEO Ron Najafi, PhD. "As resistance to antibiotics becomes a critical public health issue, NovaBay intends to aggressively pursue the development of our non-antibiotic anti-infectives as a first-line treatment for a range of topical infections."

This double-blind, randomized, dose-ranging study examined the safety and clinical efficacy of NVC-422 for the topical treatment of patients with impetigo due to Staphylococci, including those patients with drug-resistant strains of bacteria called methicillin-resistant Staphylococcus aureus or MRSA, as well as patients with infections due to Group A beta-hemolytic streptococci (also known as Streptococcus pyogenes). The trial was conducted at two experienced clinical centers in the Dominican Republic. Patients were treated with low, medium or high doses of NVC-422 gel three times a day for seven days. Clinical response and bacteriological efficacy were evaluated after one week of treatment and during a follow-up visit one week later. Clinical response was evaluated using the Skin Infection Rating Scale (SIRS), a widely used numerical scale.

"The results of this trial are very encouraging for the medical community. If NVC-422 were approved, physicians would potentially have a weapon against superficial skin infections caused by MRSA," said Dr. Richard Odom, former president of the American Academy of Dermatology and former chair and current professor of clinical dermatology at UCSF. "As importantly, we in the medical profession would not have to worry about whether the infection was resistant or not, allowing us to prescribe one treatment without the cost or time involved in conducting cultures and lab tests to determine the causative strain of infection."

NovaBays Aganocide compounds are proprietary, synthetic N-chlorinated, antimicrobial molecules specifically designed to mimic how the bodys own white blood cells fight infection, making them unlikely to cause resistance. In preclinical testing, NovaBays Aganocide compounds have shown to be highly effective against bacteria, including drug-resistant strains, viruses and fungi.

Based on the encouraging results of this trial, NovaBay intends to present its development plans for NVC-422 for the treatment of impetigo to the Food and Drug Administration (FDA). NovaBay also plans to evaluate this drug for the treatment of additional superficial skin and skin structure infections, including atopic dermatoses, secondarily infected lesions and simple abscesses, which represent large market opportunities. Uncomplicated skin infections account for almost 200 million physician visits in the United States annually, with treatment costs estimated to be in excess of $350 million each year.