NovaBay Pharmaceuticals Inc., a clinical-stage biotechnology company developing its first-in-class, anti-infective Aganocide compounds for the local non-systemic treatment and prevention of infections, announced that it has selected multiple organizations to manage the company’s phase II b clinical study of NVC-422 for the treatment of adenoviral conjunctivitis, a form of “pink eye.” This global study is anticipated to enroll up to 450 patients with confirmed adenoviral conjunctivitis at investigational sites in India, Brazil, and the United States.
“We are pleased to be working with Quintiles in India, Chiltern International in Brazil, and Symbio, LLC in the US for our next ophthalmic clinical study” said Dr David Stroman, senior vice president, Ophthalmic Drug Development at NovaBay. “I have managed successful global clinical trials in the past and have confidence these CROs are the optimal choice for our upcoming trial. We are very encouraged by the clinical findings from the previous NVC-422 conjunctivitis study. These data from our first safety and efficacy study demonstrated clinically meaningful resolution of signs and symptoms associated with adenoviral conjunctivitis. Based on these findings, we have chosen appropriate clinical endpoints for the primary efficacy measures in our phase II b study. We believe this strategy will support the design of future registration studies.”
“Globally, adenoviral conjunctivitis remains the greatest unmet medical need across all ocular infections,” said Dr Ron Najafi, chairman and chief executive officer of NovaBay. “In the previous study, our lead Aganocide compound, NVC-422, was effective against multiple adenoviral serotypes, particularly those that cause epidemic keratoconjunctivitis, or EKC, which affects the cornea and can be vision-threatening. We believe NVC-422 could represent a significant advancement in the treatment of adenoviral conjunctivitis, particularly in treating EKC, which represents an estimated 50% of the adenoviral conjunctivitis infections, and an even higher percentage during epidemic outbreaks.”
NovaBay’s phase II b clinical trial of NVC-422 for the treatment of adenoviral conjunctivitis is expected to begin enrolling patients in the second quarter of 2012. Pending successful completion of the phase II b study, NovaBay may seek a partner for phase III registration studies through commercialization.
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.
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 and 37. It 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 in rare cases even years. Since the disease is often epidemic in nature, it is called epidemic keratoconjunctivitis.
NovaBay Pharmaceuticals is focused on developing its proprietary and patented Aganocide compounds.