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®, today announced that partner Galderma S.A., a global leading pharmaceutical company exclusively focused on dermatology, has initiated the South African arm of its Phase 2b clinical study of a proprietary topical formulation of NVC-422 (CD07223) for the treatment of impetigo.
“The treatment of impetigo is a significant unmet need in South Africa, and the expansion of this international study into that market is an important step for our partner Galderma,” said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay. “Our hope is that our Aganocide treatment will be able to bring relief to the patients suffering from impetigo, many of them children, around the world.”
Designed to confirm efficacy and evaluate two different dosage regimens, the study is expected to enroll over 300 patients at 24 clinical sites in four countries worldwide. The first patients were enrolled in the U.S. arm of the study in September 2012. Galderma previously established preclinical and clinical safety for topical NVC-422, including the successful completion of safety studies involving more than 300 healthy volunteers, as well as the feasibility of manufacturing scale-up and long-term shelf-life.
Impetigo is a highly contagious skin infection that mainly affects infants and children, which is caused by Staphylococcus aureus, including MRSA (methicillin-resistant Staphylococcus aureus), Streptococcus pyogenes, or both. There have been increasing reports of skin infections caused by MRSA from local and regional health departments, physicians, schools, and daycare facilities.1 A review article published recently in Pediatric Dermatology2 reported that antibiotic-resistant organisms have become more prevalent in impetigo, and that the disease should be treated with topical agents that will reduce antibacterial resistance and minimize the incidence of adverse events.
In a previous Phase 2 clinical study, NVC-422 was shown to be safe and well tolerated. NVC-422 gel also demonstrated a clinical response rate of 92% and a microbiological response rate of 95% at the same dosage used in the current Phase 2b study. Furthermore, in a subset of patients who enrolled in the study with MRSA infections, NVC-422 gel demonstrated clinical and microbiological response rates of 100%.3 Additionally, NVC-422 was rapidly bactericidal against 55 clinical isolates of MRSA acquired from a database of patients in the U.S. and Europe.
1Pollard JM, Rice CA, (2007) MRSA: Antibiotic resistant staph infection; HealthHints Newsletter. Full text available: http://fcs.tamu.edu/health/healthhints/2007nov/mrsa.php
2Bangert S, Levy M, and Hebert AA, (2012) Bacterial Resistance and Impetigo Treatment Trends: A Review; Pediatric Dermatology Vol. 29 No. 3 243–248. Abstract available: http://onlinelibrary.wiley.com/doi/10.1111/j.1525-1470.2011.01700.x/abstract
3Iovino SM, Krantz KD, Blanco DM, Fernández JA, Ocampo N, Najafi A, Memarzadeh B, Celeri C, Debabov D, Khosrovi B, Anderson M., (2011) NVC-422 topical gel for the treatment of impetigo.; Int J Clin Exp Pathol. Aug 15;4(6):587-95. Abstract available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3160610/
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 second half 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.
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This release contains forward-looking statements, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding NovaBay’s expectations on the benefits from its relationship with Galderma, NovaBay’s expectation on the potential efficacy of Aganocide compounds for the treatment of impetigo and other indications the expected timing of enrollment and commencement of clinical trials, expected timing of receipt and announcement of results of clinical studies, and expected future financial results. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in development, clinical trial, regulatory approval, production and marketing of the company’s product candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates, the uncertainty of patent protection for the company’s intellectual property or trade secrets, the company’s ability to obtain additional financing as necessary and unanticipated research and development and other costs. Other risks relating to NovaBay and Aganocide compounds, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading “Risk Factors.” The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.
NovaBay Pharmaceuticals Contacts
Thomas J. Paulson
Chief Financial Officer
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