When NB-002 is applied around the human nail, the droplets traverse skin pores and hair follicles delivering substantial concentrations into the epidermis and dermis. NB-002 then laterally diffuses under the full width of the nail achieving concentrations that are 50 times the minimal fungicidal concentration. NB-002 has strong fungicidal activity against the dermatophytes that cause onychomycosis including non-growing resting forms of the organism as well as azole-resistant species. Supporting data was presented 10/27/2008 during the ICAAC/IDSA meeting in Washington, DC:
Results from a Phase 1 study, as well as published preclinical data, indicate that NB-002 can be safely applied to the skin at doses more than 1,000 time higher than the minimum concentration required to kill the responsible fungi in vitro.
NB-002 demonstrated a robust clinical response in patients suffering from mild onychomycosis as well as an excellent safety profile in a randomized, double-blind, vehicle-controlled Phase 2 study involving 443 subjects. Each of the subjects were culture proven to have onychomycosis and received 42 weeks of daily topical applications without nail debridement. Nail clearing and cultures were evaluated eight weeks after the end of treatment. Based on these data, NanoBio is proceeding in the development of NB-002 as as the first FDA-approved OTC treatment for mild onychomycosis.
Additional data demonstrates that when an antifungal is combined with NB-002, the antifungal agents diffuses under the nail from adjacent skin sites to kill the fungi that cause onychomycosis:
NB-002 with the addition of an approved antifungal provides several compelling opportunities including prescription products for onychomycosis, tinea capitis and difficult-to-treat fungal infections.