(RTTNews) - NovaBay Pharmaceuticals Inc. (NBY: News ) announced Wednesday that in the mid-stage study of its lead compound NVC-422 for adenoviral conjunctivitis, the primary endpoint of sustained microbiological success of 20% greater than placebo was not met.NVC-422 is the lead molecule in the Aganocide class discovered and patented by NovaBay. NovaBay has licensed the use of the Aganocide compounds to Alcon for use in the treatment of eye, ear and sinus infections and for use in contact lens solutions. The rights to all other uses of this class of compounds have been retained by NovaBay.
Alcon commenced the phase II clinical trial of NVC-422 for viral conjunctivitis, a type of "pink eye" in July 2009. The trial enrolled 452 patients who were randomized 1:1 for treatment with NVC-422 ophthalmic solution or its vehicle as placebo. Of the total patients enrolled in the trial, 81 patients were confirmed to have adenoviral conjunctivitis. Some of the patients enrolled in the trial were infected with adenovirus serotypes commonly associated with epidemic keratoconjunctivitis.
For primary endpoint analysis, only day 5 or 7 were selected and the predetermined primary endpoint was sustained microbiological success of 20% greater than placebo. In the clinical trial, success was defined as sustained eradication of adenovirus that remained eradicated at all subsequent visits. company.
NovaBay added that though the study failed to meet the primary endpoint, encouraging and unexpected results were found in the 38% of patients infected with adenovirus serotypes commonly associated with EKC (epidemic keratoconjunctivitis).
According to the company, the clinical results were most impressive in patients infected with viruses associated with EKC, the condition which is most likely to result in severe damage to the vision of infected patients, and which is of primary concern to the ophthalmology community.
NovaBay added that it will take the next steps for the Aganocide ophthalmology program after reviewing the phase II data of NVC-422 with its partner Alcon and other experts in the ophthalmic community.
NBY closed Tuesday's trading at $2.08. The stock has thus far hit a 52-week low of $1.64 and a 52-week high of $2.55.