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news.NovaBay Pharma's Phase 2a proof-of-concept clinical trial evaluating NVC-422 was shown to be safe and efficacious against the highly contagious skin infection impetigo.
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NovaBay Pharma’s dose-ranging study showed that the drug cleared impetigo infections, including those in the trial caused by a drug-resistant strain of bacteria called methicillin-resistant Staphylococcus aureus or MRSA.
NovaBay Pharma said that the double-blind, randomised, dose-ranging study examined the safety and clinical efficacy of NVC-422, in all three doses that is low, medium and high doses, for the topical treatment of patients with impetigo due to Staphylococci, including those patients with drug-resistant strains of bacteria called methicillin-resistant Staphylococcus aureus (MRSA), as well as patients with infections due to Group A beta-hemolytic streptococci (also known as Streptococcus pyogenes).
Clinical response was evaluated using the Skin Infection Rating Scale (SIRS), a widely used numerical scale.
The response rate for the 10 patients infected with MRSA who completed treatment was 100%. These response rates compare favorably to previously published results from studies of topical antibiotics, and are substantially higher than the historical placebo response rates of 30-50%. The results showed a trend towards a dose response, and the treatment was well-tolerated.
NovaBay Pharma added that, based on the results of the trial, it intends to present its development plans for NVC-422 for the treatment of impetigo to the FDA. NovaBay is also expected to evaluate this drug for the treatment of additional superficial skin and skin structure infections, including atopic dermatoses, secondarily infected lesions and simple abscesses.
Ron Najafi, CEO of NovaBay Pharma, said: “This clinical trial is a validation of our Aganocide platform technology, which produces anti-infectives that would be unlikely to cause drug resistance. NovaBay intends to pursue the development of our non-antibiotic anti-infectives as a treatment for topical infections.”