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news.NovaBay Pharmaceuticals has reported encouraging results from a double-blind placebo-controlled Phase I trial studying its lead aganocide compound NVC-422, a novel non-antibiotic anti-infective that has shown potent in vitro activity against major pathogens, including methicillin-resistant Staphylococcus aureus.
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The results of the Phase I trials show that when topically applied to the anterior nares (the lower nasal passages), NVC-422 appears safe and well tolerated, with undetectable systemic exposure.
Based on these results, NovaBay has commenced a second Phase I trial to test the safety of NVC-422 at a higher dose and expects to have results from this second study by early 2008.
In parallel with the second Phase I study, NovaBay expects to commence a Phase IIa study by January 2008 in healthy volunteers that are carriers of Staphylococcus aureus in their nasal passages.
Ron Najafi, NovaBay’s chairman and CEO, said: “AgaNase (NVC-422 for nasal applications) has the potential to be an important treatment option for physicians in the ongoing fight against drug-resistant infections, including MRSA, a growing public health concern in the hospital. With this excellent preliminary safety data, we intend to move forward into additional trials to study the safety and efficacy of NVC-422 in volunteers and patients at risk of infection.”