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.
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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.
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By GlobalData“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.
