Feb 21 2013
NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with first-in-class compounds such as its proprietary Aganocides®, announced that the World Health Organization (WHO) has approved the international nonproprietary name (INN) “auriclosene” (pronounced awr-rih-CLO-zeen) for the Company’s lead Aganocide® compound NVC-422. INNs facilitate the identification of active pharmaceutical ingredients, and each INN is a globally recognized unique name.
Aganocides are NovaBay’s first-in-class topical antimicrobial compounds, which are active against viruses, fungi, and bacteria, including the bacteria that grow and thrive under biofilm. Testing in-vitro and in-vivo has shown that these non-systemic, non-antibiotic compounds do not give rise to bacterial or fungal resistance. Phase 2 studies for auriclosene are currently ongoing in urology, ophthalmology, and dermatology.
Dr. Ron Najafi, Chairman and Chief Executive Officer, said, “Obtaining the INN for our lead clinical compound NVC-422 confirms that our clinical development is on track, and we anticipate progression into Phase 3 development in each of our three Aganocide programs. We also intend to conduct a Phase 2a proof-of-concept study for auriclosene in an additional ophthalmic indication. NVC-422, now auriclosene, is the first of our proprietary Aganocides to receive a nonproprietary name.”
About NovaBay Pharmaceuticals, Inc.
Going Beyond Antibiotics
NovaBay Pharmaceuticals is a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with its two distinct categories of compounds, Aganocides® and NeutroPhase® Skin and Wound Cleanser. The Company’s four core business units, DermaBay, UroBay, EyeBay and MediBay, are developing treatments that tackle infections in the dermatology, urology, ophthalmology, and wound care areas.
NovaBay’s first-in-class Aganocide compounds, led by NVC-422, are patented, topical antimicrobials with a broad spectrum of activity against bacteria, viruses and fungi. Mimicking the mechanism of action that human white blood cells use against infections, Aganocides are not subject to bacterial or fungal resistance, which has been demonstrated in in-vitro and in-vivo studies. Having demonstrated clinical efficacy in Phase 2 proof-of-concept clinical studies, NVC-422 is suited to treat and prevent a wide range of local, non-systemic infections. NovaBay’s clinical development activities are focused on three disease areas:
Dermatology – Partnered with Galderma, a leading dermatology company, to develop a formulation of NVC-422 for treatment of highly contagious skin infection, impetigo, which occurs most commonly in children. Enrollment into a global Phase 2b clinical study has begun and clinical data results are expected in the second half of 2013.
Ophthalmology – NovaBay is developing an eye drop formulation of NVC-422 for treating adenoviral conjunctivitis, a highly contagious viral eye infection for which there is no approved acute treatment. Enrollment into a global Phase 2b clinical study has begun, and clinical data results are expected in the second half of 2013.
Urology – NovaBay's urinary catheter irrigation solution containing NVC-422 is currently in a Phase 2b study, with the goal of reducing the incidence of urinary catheter blockage and encrustation (UCBE) and associated urinary tract infections. The Company reported positive data from the Phase 2a study and is evaluating the effect of an alternate more potent formulation of NVC-422 in Phase 2b. Results are expected in the first half of 2013.
NeutroPhase is the only pure hypochlorous acid (HOCI) skin and wound cleanser cleared by the U.S. Food and Drug Administration (FDA) to target the six-million-patient U.S. market of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers. The saline-based solution is the only wound cleanser on the market to include a stabilized, pure form of HOCl shown in studies to kill bacteria in solution, including flesh-eating bacteria. For additional information, visit: www.neutrophase.com.