Results from a Phase I 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.
The ongoing randomized, double-blind, vehicle-controlled study involving 443 subjects is being conducted at 22 sites in the US 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.
James Baker, Jr., founder and chairman of NanoBio, said: “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.”