NovaBay Pharmaceuticals, Inc., is developing aganocide compounds for use as antiinfective agents to treat ophthalmic, urologic, dermatologic, and hospital infections. According to Ron Najafi, PhD, chairman and CEO of the company, aganocides are analogues of natural compounds that are made by white blood cells when they fight off bacteria, viruses, and other microorganisms.
“When white blood cells capture bacteria in the body, they produce a series of compounds called chlorotaurines. Dr. Najafi said in an interview with Cataract & Refractive Surgery Today, “We have chemically modified these compounds so that, unlike their naturally occurring counterparts, they have an extended shelf life and thereby have commercial potential. We have extensive patents around this novel technology, and we are developing these compounds for market opportunities where antibiotics are currently the leading products, but are becoming ineffective due to the development of bacterial resistance.”
NEW CLASS OF DRUG
Dr. Najafi said that the company is interested in developing an alternative to antibiotics because of the rise in bacterial resistance. “Antibiotic use puts pressure on bacteria and causes them to modify and change,” he said. “Aganocide compounds do not give rise to resistance because of the way that they attack bacteria.” Early research by the company and its partners has repeatedly confirmed this claim. NovaBay Pharmaceuticals, Inc., is exploring the development of aganocides for the treatment of bacterial and viral ocular infections as well as skin infections such as impetigo.
The company recently announced the results of a phase 2 proof-of-concept clinical study of NVC-422 for the treatment of adenoviral conjunctivitis. Of the 452 patients randomized 1:1 to treatment with the agent or its vehicle as placebo, 81 were confirmed by laboratory findings to have adenoviral conjunctivitis. Although the predetermined primary endpoint of sustained microbiological success of 20% greater than placebo on day 5 or 7 was not met, Dr. Najafi noted that other encouraging and potentially more important results were observed instead (see Phase 2 Clinical Trial of NVC-422 for Adenoviral Conjunctivitis).
It was confirmed that 38% of the included patients were infected with adenovirus serotypes commonly associated with a highly contagious and vision-threatening condition known as epidemic keratoconjunctivitis (EKC). An additional efficacy analysis of this subset found that the treatment positively affected patients’ clinical signs, symptoms, and microbiological findings. Dr. Najafi said that, importantly, a beneficial effect was seen for sustained clearing of blurred vision in all patients treated with NVC-422 versus placebo.
“We think NVC-422 was effective against EKC because the drops are delivered to the corneal surface, which is more receptive to the treatment than the conjunctiva,” he said. “We are particularly pleased to find that 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. If future clinical trials with a larger number of patients confirm these results in a statistically significant manner, we believe we will have a new therapy for viral conjunctivitis and its potential damage to the cornea.”
Dr. Najafi said that adenoviral conjunctivitis represents an unmet medical need in that there are no FDA-approved treatments. “The important thing is that, when someone presents with conjunctivitis, the ophthalmologist cannot tell if the cause is bacterial or viral,” he commented. “If the cause is viral and antibacterial products are administered, they will not have an effect.”
“The challenge is for us to develop an eye drop that has antibacterial and antiviral activities, and this technology has both,” he added. “We were also very encouraged by the fact that the treatment was well tolerated.” For other study details, see Confirmed Activity of Aganocides Against Ophthalmic Pathogens: ARVO.
Dr. Najafi said that the company has regained worldwide rights to its aganocide compounds from Alcon Laboratories, Inc., including all previously licensed areas in ophthalmic, otic, and sinus applications. NovaBay Pharmaceuticals, Inc., is free to continue the development of aganocides for these areas on its own or in collaboration with new partners. The company is planning a multicountry phase 2b trial to be conducted in 2012. Pending successful completion of this trial, the company expects to seek a partner for phase 3 registration studies through commercialization.
Ron Najafi, PhD, is the chairman and CEO of NovaBay Pharmaceuticals, Inc. Dr. Najafi may be reached at rnajafi@novabaypharma.com.
