NovaBay reports encouraging preclinical results from fungal infection trial

NovaBay said that the study of NVC-422, which is a synthetic bioequivalent form of the most effective and rapidly acting anti-infective molecules produced by white blood cells, revealed significant clinical and mycological efficacy compared to the untreated control group at all doses evaluated, with the highest clinical and mycological efficacy rates of 36.6% (p<0.0001) and 97.9% (p<0.05), respectively, achieved in the highest dose group. These data confirm previous preclinical results that showed a high level of activity for high dose NVC-422 against dermatophytes, the company noted. NovaBay plans to file an exploratory investigational new drug application with the FDA in the second quarter of 2009 and initiate a Phase II clinical trial of NVC-422 during the second half of 2009 for impetigo. In Phase I human studies, NVC-422 has been shown to be safe and well-tolerated in the nose and bladder, said NovaBay. Also, a Phase I trial with NVC-422 for the treatment of eye infections has commenced under the auspices of NovaBay's partner Alcon. Ron Najafi, chairman and CEO of NovaBay, said: "In developing anti-infective compounds, experience shows that preclinical results are more predictive of clinical efficacy than in other therapeutic categories, and I am encouraged that our preclinical work to date strongly suggests that NVC-422 may be a potent and well-tolerated treatment for numerous serious skin infections such as acne, nail fungus and topical viral infections, where antibiotics are not effective."