Mar 24 2008
NanoBio Corporation has announced that it has seen promising results from an interim analysis of its phase 2 study of NB-002, a topical lotion for onychomycosis (nail fungus). Although the details remain confidential, the results clearly justify completing the study, according to NanoBio scientists.
"Allowing adequate time for subjects to grow out a clear nail after successfully treating the infection will enable us to generate data on complete cure, the primary endpoint required by the FDA for approval of drugs to treat onychomycosis," said James R Baker Jr., M.D., founder and chairman of NanoBio Corporation.
The ongoing randomized, double-blind, vehicle-controlled study involving 443 subjects is being conducted at 22 sites in the United States and Canada. The interim analysis was performed on the first 160 subjects from the trial to complete the 24 week assessment of clear nail growth. Final results will be available in the first quarter of 2009.
The analysis confirmed the outstanding safety profile of NB-002 seen in previous human and animal trials, Baker said. Results from a phase 1 study in onychomycosis, as well as preclinical data, indicated that the product can be safely applied to the skin at doses more than 1,000 times higher than the minimum concentration required to kill fungi. In total, over 900 subjects have been treated with the NB-002 formulation without significant skin irritation, systemic absorption, or other safety concerns.
"NB-002 exerts its effect locally by penetrating to reach the nail bed where dermatophytes responsible for onychomycosis reside. It then kills both active hyphae and spores, without irritating the epithelium or being systemically absorbed," Baker said.
"The absence of systemic absorption provides a significant advance for onychomycosis therapy in terms of safety. Current oral (systemic) drugs for onychomycosis pose risks of hepatic and cardiac toxicity, as well as the potential for drug interactions," Baker added.
NB-002 has documented fungicidal activity against numerous fungi involved in cutaneous infections, including Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis and Candida albicans.
Onychomycosis is a chronic, persistent fungal infection of the nail bed resulting in unsightly thickening and discoloration of the nail, which sometimes can be accompanied by pain and disability. According to Podiatry Today, more than 35 million people in the United States have onychomycosis. Estimates indicate that up to 50 percent of those affected by the disease do not receive treatment.
Systemic treatments represent well over 80 percent of the market today, but they have potential toxicity issues and have shown to have relapse rates of 40 percent or higher. The only approved topical treatment for onychomycosis has demonstrated an efficacy rate ranging from 5 percent to 12 percent.