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, announces a successful meeting with the US Food and Drug Administration (FDA) to discuss the Company's clinical development of its Aganocide® compound NVC-422, intended for use in the treatment of impetigo.
"We had a very positive meeting with the FDA on our clinical development of NVC-422 for impetigo. The FDA provided valuable input on the design of our Phase 2b trial, timing of additional clinical and other studies needed for a New Drug Application (NDA)," said Ron Najafi, Ph.D, NovaBay's Chairman and CEO. "We are moving forward to implement the FDA's suggestions."
NovaBay recently reported positive results for the use of NVC-422 topical gel in the treatment of impetigo from a 129 patient, randomized, double-blind, dose-ranging Phase 2a clinical trial. The trial showed high clinical and bacteriological efficacy of three concentrations of the drug applied ranging from 84% to 95% at end of treatment and at follow up. These response rates compare favorably to previously published results from studies of topical antibiotics, and were substantially higher than the response rate (30-50%) anticipated for placebo. The treatment was well tolerated with the few adverse events reported being mild to moderate in severity and all resolved after the end of treatment. Additionally, the response rate for all patients infected with MRSA who completed treatment was 100%.
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