Study Design Includes FDA Recommendations Following Successful End-of-Phase 2a Meeting
EMERYVILLE, Calif., May 17, 2012 (GLOBE NEWSWIRE) -- NovaBay Pharmaceuticals, Inc. (NYSE AMEX:NBY), a clinical-stage biotechnology company developing novel anti-infective products for the treatment and prevention of topical infections, today announced that it has enrolled the first patients in its global Phase 2b clinical study. The study (named BAYnovationTM) will evaluate the Company's lead compound, NVC-422, for treating adenoviral conjunctivitis, a highly contagious form of "pink eye."
After providing certain suggestions and insight into the design of BAYnovation at an End-of-Phase 2A meeting, the Food and Drug Administration (FDA) confirmed that the trial has all the design elements (controls, sample size, end-points) of a pivotal trial.
"We are very pleased with the guidance that we have received from the FDA and we are excited to launch BAYnovation as a global clinical trial to develop a treatment for adenoviral conjunctivitis," said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay. "We believe the FDA recognizes the need for a well-tolerated, topically administered therapy in this indication, as there is no current treatment for viral conjunctivitis. We look forward to continuing clinical development of NVC-422 and working closely with the FDA to ensure this product reaches the market as quickly as possible."
"Viral conjunctivitis remains the largest untreated ocular infection globally," commented Dr. David Stroman, Ph.D., Senior Vice President, Ophthalmology at NovaBay Pharmaceuticals. "I am personally thrilled that patient enrollment has begun in this new conjunctivitis study, the design of which was based on the important clinical findings seen in the previous study of NVC-422. NovaBay is committed to providing a novel therapeutic solution for the millions of Americans and people around the world who suffer from this highly contagious ocular infection every year."
Previously, NovaBay reported very encouraging data from its Phase 2a clinical study, which suggested that NVC-422 may be efficacious in patients infected with adenoviral serotypes associated with epidemic keratoconjunctivitis (EKC), the most highly contagious and potentially sight-threatening form of adenoviral conjunctivitis.
About BAYnovation Phase 2b Study
BAYnovation will evaluate the Company's lead compound, NVC-422, for treating adenoviral conjunctivitis, a highly contagious form of "pink eye." This global study is anticipated to enroll approximately 450 patients with confirmed adenoviral conjunctivitis at investigational sites in India, Brazil, and the United States. NovaBay has partnered with leading CROs – Quintiles in India, Chiltern International in Brazil, and Symbio, LLC in the U.S. – to conduct BAYnovation. For more information on BAYnovation, please visit www.clinicaltrials.gov/ct2/show/NCT01532336.
About Adenoviral Conjunctivitis ("Pink Eye")
Adenoviral conjunctivitis, a highly contagious ocular infection, is an unmet medical need, with no effective treatment. Conjunctivitis is an inflammation of the conjunctiva, a thin, transparent layer covering the surface of the inner eyelid and the front of the eye. It affects people of all ages. Acute conjunctivitis from various etiologies is characterized by common symptoms and signs including a red eye, discharge, eyelash matting or crusting, foreign body sensation, and tearing. Adenovirus is a very robust virus that can survive outside the body on hard surfaces and has been cultured from such surfaces up to 7 weeks after an infection. Approximately 45% of people in a patient's close surroundings, e.g., family members, will become infected. Although exact numbers are difficult to determine, estimates suggest the number of cases of ocular adenoviral infections may be as high as 5-10 million per year in the United States.
About Epidemic Keratoconjunctivitis (EKC)
Epidemic keratoconjunctivitis (EKC) is a serious and contagious eye infection affecting both the conjunctiva and, more problematically, the cornea (the transparent front part of the eye that covers the iris, pupil, and anterior chamber). EKC infections are commonly associated with adenoviruses types 8, 19, 37 and 54. EKC is characterized by conjunctivitis, acute onset of watering, redness, foreign body sensation, blurred vision and severe pain. Patients affected by EKC are often advised by physicians not to attend work or school anywhere from 1-2 weeks leading to loss of work time and absenteeism. In aggressive cases of EKC, corneal scarring due to subepithelial infiltrates (SEIs) and conjunctival scarring due to membrane or pseudo membrane can be seen. During the acute phase, which persists for approximately two to three weeks, viruses are present and replicating. In the typical case, first one eye is infected, after which the infection spreads to the other eye within two to three days. Both eyes are affected in 60% of cases. The infection in the first eye is typically the more serious. In approximately 20-50% of patients, corneal opacities are developed due to SEIs, resulting in deteriorating vision that remains for weeks and months, and even years. Corneal transplants are sometimes the medical remedy to the deteriorated vision. Since this form of adenoviral conjunctivitis often occurs in epidemic outbreaks, it is called epidemic keratoconjunctivitis.
About NovaBay Pharmaceuticals, Inc.
Going Beyond Antibiotics
NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with its two distinct categories of products.
Aganocide® Compounds
NovaBay's first-in-class Aganocide compounds, led by NVC-422, are patented, synthetic molecules 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 possess a reduced likelihood that bacteria or viruses will be able to develop resistance, which is critical for advanced anti-infectives. 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:
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Dermatology - Partnered with Galderma, a leading dermatology company, to develop a formulation of NVC-422 for treatment of highly contagious skin infection, impetigo, caused primarily by S. aureus and Group A b-hemolytic streptococci. A major global Phase 2b clinical study is planned for 2012.
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Ophthalmology - NovaBay is developing an eye drop formulation of NVC-422 for treating adenoviral conjunctivitis. Enrollment into a global Phase 2b clinical study has begun with top-line data expected in the first half of 2013.
- Urology – NovaBay's urinary catheter irrigation solution containing NVC-422 is currently enrolling patients in its Phase 2 proof-of-concept clinical studies, 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 Part A of this study and expects to announce top-line results from Part B later in 2012.
NeutroPhase®
NovaBay is also developing NeutroPhase, which is an FDA 510(k)-cleared product for advanced wound care. We believe that NeutroPhase is the only patented pure hypochlorous acid solution available and has the potential to be best suited to treat the six-million-patients in the U.S. who suffer from chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers.
For additional information, visit: www.neutrophase.com.
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Forward Looking Statements
This release contains forward-looking statements, which are based upon management's current expectations, assumptions, estimates, projections and beliefs. Statements regarding NovaBay's expectations including, but not limited to, (i) the anticipated number of patients that will enroll in the Phase 2b conjunctivitis trial and the expected timing of the results of the trial; (ii) any potential plans for future clinical development of its Aganocide compounds and of bringing products to market including the expected timing of the initiation of the Phase 2b impetigo clinical trial and expected timing of the results of the Phase2 Part B UCBE trial; (iii) the potential efficacy of Aganocide compounds; (iv) the development and potential benefits of, and the market opportunities for, NovaBay's product candidates (v) the potential to deliver the same or better efficacy than antibiotics and to address the growing problem of antibiotic resistance as well as other statements that relate to future events or results, are forward-looking. 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: the risk that negative results from the development programs could preclude Galderma from providing additional funding to NovaBay; inherent risks and uncertainties relating to difficulties or delays in conducting clinical trials; the inherent uncertainty of patent protection for the company's intellectual property or trade secrets, risks and uncertainties relating to difficulties or delays in discovery, development, testing, production and marketing of the company's product candidates; unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates; the company's ability to obtain additional financing as necessary; and the risk of unexpected delays in the regulatory process which may delay the commencement or completion of clinical trials. 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 Quarterly Report on Form 10-Q for the period ended March 31, 2012, under the caption "Risk Factors" in Item 1A of Part II of that report, filed with the Securities and Exchange Commission on May 3, 2012. 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.