NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a clinical-stage biopharmaceutical company developing non-antibiotic, topical antimicrobial products, today announced it has completed enrollment of patients in its global Phase 2b viral conjunctivitis trial, BAYnovation. The trial is investigating NovaBay’s Auriclosene (NVC-422) Ophthalmic Solution as a treatment for adenoviral conjunctivitis, a highly contagious, potentially sight-impairing form of “pink eye”. This condition affects millions of people globally and there is currently no approved treatment available anywhere in the world. NovaBay expects to report results from its trial in mid-2014.
BAYnovation is a multi-centered, randomized clinical study that has enrolled patients with adenoviral conjunctivitis in the United States, India, Sri Lanka, and Brazil. Patients were enrolled into the study by 54 clinical investigators, including 18 in the US, 19 in India, 6 in Sri Lanka and 11 in Brazil. BAYnovation was designed to evaluate the efficacy of NovaBay’s Auriclosene Ophthalmic Solution in the treatment of adenoviral infection, specifically clearing the associated red eye and reducing lingering effects left by the infection.
David Stroman, Ph.D., the Senior Vice President of Ophthalmology at NovaBay Pharmaceuticals commented, “Treatment for adenoviral conjunctivitis is acutely needed to combat the epidemics caused by adenovirus. We are looking forward to unmasking data and reporting trial results in the middle of 2014.”
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
NovaBay Pharmaceuticals is a clinical-stage biopharmaceutical company focused on addressing the unmet therapeutic needs of the global, topical anti-infective market with its Aganocide® compounds, led by auriclosene. Auriclosene is a new chemical entity invented by NovaBay and has a broad spectrum of activity against bacteria, viruses and fungi. Aganocide compounds are based on the human body’s natural immune system and the molecules involved in combating infections. Bacterial resistance to Aganocides is highly unlikely, as demonstrated in in vitro studies. Once pathogens penetrate the body’s primary defense, the next line of defense is provided by the white blood cells. NovaBay has focused on understanding these molecules generated by the white blood cells and finding ways, by chemical modification, to allow them to be developed as therapeutic products with the potential to treat a wide range of local, non-systemic infections. NovaBay believes that if Aganocides begin to supplement and thereby reduce the usage of classic topical antibiotics, they will help slow the rise of antibiotic resistance.
This release contains forward-looking statements and opinions, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the efficacy of NovaBay’s Auriclosene Ophthalmic Solution and the potential market worldwide. The words “potential,” “believe” and “will” are intended to identify these forward-looking statements. 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 latest 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.
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NovaBay Pharmaceuticals, Inc.
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