Galderma, a pharmaceutical company, and NovaBay Pharmaceuticals, a biotechnology company, have enrolled their first patient in a Phase IIb study of NVC-422 (CD07223) for the treatment of impetigo.
The study, which is designed to assess the efficacy and to evaluate two different dosage regimens of the topical formulation of NVC-422, will enrol over 300 patients at 24 clinical sites in four countries worldwide.
Galderma CEO 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 commercialisation."
Galderma has confirmed preclinical and clinical safety of topical NVC-422 and completed safety studies involving more than 300 healthy volunteers, in addition to the feasibility of manufacturing scale-up and long-term shelf-life.
NVC-422 was safe and well tolerated in a Phase II study and demonstrated a 100% response rate for treating patients with impetigo caused by methicillin-resistant Staphylococcus aureus (MRSA).
NovaBay chairman and CEO Dr Ron Najafi said NVC-422 will be the first non-antibiotic anti-infective to 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 said.
Impetigo is a highly contagious skin infection that primarily affects infants and children, which is caused by Staphylococcus aureus, including MRSA, Streptococcus pyogenes, or both.