NovaBay® Pharmaceuticals, Inc. (NYSE Amex:NBY) announced today that its development partner, Alcon Research, Ltd., has concluded its "proof of concept" clinical trial of NovaBay's patented lead Aganocide® compound, NVC-422 for the treatment of viral conjunctivitis; a highly contagious eye infection for which there are currently no marketed products. Adenoviral infections are the most common form of viral conjunctivitis. Alcon and NovaBay will be analyzing the microbiological and clinical efficacy of the drug vs. placebo in all 81 adenovirus positive patients enrolled in the trial and plan to report on these analyses in early 2011. The decision to conclude the study as currently designed was based on an interim analysis of the first 50 adenovirus positive patients and a lower than expected rate of recruitment of adenovirus positive patients in the U.S. This analysis showed, that for patients presenting less than 3 days after the onset of symptoms, microbiological efficacy of NVC-422 vs. an inactive placebo was 8% better on day 3>
NovaBay chairman and CEO, Ron Najafi, Ph.D., commented, "We will complete a comprehensive analysis on all 81 patients finishing the study and believe that the larger patient sample size will provide a statistical framework from which we can determine the next steps in the clinical development of our Aganocides."
Initiated in July 2009 this Phase 2 multi-center, randomized, placebo-controlled clinical trial was designed to evaluate the safety and efficacy of NovaBay's lead Aganocide, NVC-422 ophthalmic solution for the treatment of adenoviral conjunctivitis. Alcon and NovaBay plan to analyze the full data set from the study to comprehensively understand the nature and degree of the activity observed with NVC-422. They also plan to review the optimal design of viral conjunctivitis studies in general and, more specifically, the design of studies to evaluate the potential of other compounds with the unique mechanism of action and broad-spectrum activity of NVC-422. The complete evaluation of all clinical and microbiological variables monitored during this comprehensive study will guide the next steps in the development of Aganocide compounds for the treatment of conjunctivitis. The Phase 2 viral conjunctivitis study followed a Phase 1 trial in which safety and tolerability were successfully demonstrated in 120 healthy volunteers with no reported serious adverse events.