(By Balaseshan) NovaBay Pharmaceuticals Inc. (NYSEAMEX:NBY) said it completed an end-of-phase 2a meeting with the Food and Drug Administration (FDA) regarding its NVC-422 program for treating impetigo, a highly contagious skin infection affecting millions of children and adults worldwide.
During the meeting, the FDA provided guidance related to the proposed study protocol and statistical analysis plan, as well as the overall development plan.
This valuable guidance is being incorporated into the Phase 2b protocol and analysis plan thereby enhancing the design of study.
Impetigo is a highly contagious skin infection that mainly affects infants and children. Usually, red sores appear on the face, especially around a child's nose and mouth.
Although it commonly occurs when bacteria enter the skin through cuts or insect bites, impetigo can also develop in skin that's perfectly healthy.
Implementation of the phase 2b program with NovaBay's partner Galderma S.A. is actively progressing following the successful meeting with FDA.
The company continues to work closely with Galderma's clinical, regulatory and manufacturing teams as the leadership of product development has shifted from NovaBay to Galderma and looks forward to the initiation of the global Phase 2b study in the third quarter of this year.
Over the last 12 months, in support of global product registration, Galderma has established clinical safety for topical NVC-422, including the successful completion of multiple safety studies involving more than 300 healthy volunteers, as well as the feasibility of manufacturing scale-up and long-term shelf-life.
NBY closed Tuesday's regular session up 7.92% at $1.09. The stock has been trading between $0.67 and $1.72 for the past 52 weeks.