Clinical Development:
NB-002 has demonstrated a robust clinical response and an excellent safety profile based upon an interim analysis of an ongoing randomized, double-blind, vehicle-controlled Phase 2 study, involving 443 subjects. Each of the subjects are culture proven to have onychomycosis and are receiving 42 weeks of daily topical applications without nail debridement. Nail clearing and cultures will be evaluated eight weeks after the end of treatment.
Results from a Phase 1 study, as well as published preclinical data, indicate that the product 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. In total over 900 subjects have been treated with NB-002 without significant skin irritation, systemic absorption, or other safety concerns.
Studies have confirmed that when NB-002 is applied around the human nail, NB-002 droplets traverse skin pores and hair follicles into the skin surrounding the nail. It is then substantially delivered into the epidermis and dermis and laterally diffuses under the full width of the nail achieving concentrations that are 50 times the minimal fungicidal concentration. Supporting data was presented 10/27/2008 during the ICAAC/IDSA meeting in Washington, DC.
NB-002 has also demonstrated strong fungicidal activity against the dermatophytes that cause onychomycosis including non-growing resting forms of the organism as well as azole-resistant species. |
