Date: 2012-09-24
Type of information: Initiation of preclinical development
phase: 2b
Announcement: enrollment of the first patient
Company: Galderma (Switzerland) Novabay Pharmaceuticals (USA)
Product: NVC-422 (N,N-dichloro-2,2-dimethyltaurine)
Action mechanism:
Disease: impetigo
Therapeutic area: Infectious diseases
Country:
Trial
details: The study is expected to enroll over 300 patients at 24 clinical sites in four countries worldwide and aims to confirm efficacy and evaluate 2 different dosage regimens.
Latest
news: Galderma, a global leading pharmaceutical company exclusively focused on dermatology and NovaBay Pharmaceuticals, a biotech company developing novel anti-infective products for the treatment and prevention of topical infections, including those caused by antibiotic-resistant bacterial strains, have announced that the first patients have been enrolled in the Phase 2b clinical study of a proprietary topical formulation of NVC-422 (CD07223) for the treatment of impetigo.
In further support of product registration, Galderma has established preclinical and clinical safety for topical NVC-422, including the successful completion of safety studies involving more than 300 healthy volunteers, as well as the feasibility of manufacturing scale-up and long-term shelf-life. As announced previously, following an End of Phase 2a meeting with the Food and Drug Administration (FDA) attended by both Companies, valuable guidance from the FDA has been incorporated into the Phase 2b protocol.
In a Phase 2 clinical study, NVC-422 was shown to be safe and well tolerated, and demonstrated a 100% response rate for treating patients with impetigo caused by MRSA, whether MRSA was the sole organism or in a mixed infection2 and more than a 93-95% response to all strains and full clinical response. Additionally, NVC-422 was rapidly bactericidal against 55 clinical isolates of MRSA acquired from a database of patients in the U.S. and Europe.
