NovaBay Announces Positive Phase I Study Results with Its Lead Aganocide Compound

Product Shown to be Safe as First Step Towards Its Potential Use in Controlling MRSA in Hospitals

28-Nov-2007

NovaBay Pharmaceuticals, Inc., a biopharmaceutical company developing products for the treatment or prevention of a wide range of bacterial and viral infections, reports results from a Phase I trial studying the 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 (MRSA).

Nasal colonization of Staphylococcus aureus, including MRSA, is an important risk factor that predisposes the carrier to infections during invasive hospital procedures. 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.

"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," said Dr. Ron Najafi, NovaBay's Chairman and Chief Executive Officer. "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."

In this double-blind placebo controlled Phase I trial of AgaNase, safety and tolerability were tested following repeated applications of AgaNase, using various concentrations (0.1% and 0.3%) and regimens, applied by spray or swab to the anterior nares. A total of ninety-six subjects were enrolled and completed the study. Any adverse events were local, mild, and transient and did not appear to increase at higher doses. No serious adverse events were observed in any study subject. There was no detectable systemic absorption of NVC-422 or its major metabolite.

https://www.bionity.com/en/news/74977/novabay-announces-positive-phase-i-study-results-with-its-lead-aganocide-compound.html