Galderma, NovaBay commence Phase 2b study of NVC-422

The study will enroll over 300 patients at 24 clinical sites in four countries worldwide to access the efficacy and to evaluate two different dosage regimens of the topical formulation of NVC-422.

Galderma chief executive officer Humberto Antunes said, "We share NovaBay’s enthusiasm for NVC-422, and together we expect to advance this program through late-stage clinical development, and potential approval and commercialization."

Galderma has confirmed preclinical and clinical safety of topical NVC-422 and completed safety studies besides the feasibility of manufacturing scale-up and long-term shelf-life.

NVC-422 was safe and well tolerated in a Phase 2 study which demonstrated a 100% response rate for treating patients with impetigo caused by methicillin-resistant Staphylococcus aureus.

NovaBay chairman and chief executive officer Dr. Ron Najafi said NVC -422 will be the first non-antibiotic anti-infective which will replace traditional antibiotics in the treatment of impetigo, if the trial yields successful results.

"I commend both development teams at NovaBay and Galderma on our very successful collaboration and their efforts in bringing this product closer to the finish line," Najafi added.