Clinical Development

NB-00X 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. 

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-00X without significant skin irritation, systemic absorption, or other safety concerns. 

NB-00X has also demonstrated strong fungicidal activity against all dermatophytes tested, including Trichophyton species, and azole-resistant Candida albicans.

Mechanism of Action

About Onychomycosis

Onychomycosis is a chronic persistent fungal infection of the nail bed resulting in thickening and discoloration of the nail, which sometimes can be accompanied by serious pain and disability. According to Podiatry Today, over 35 million people in the United States have onychomycosis. Estimates indicate that up to 50% of those affected by the disease do not receive treatment

Systemic treatments represent well over 80% of the market today, but have potential severe liver toxicity issues, and have shown to have relapse rates of 40% or higher. The only approved topical treatment for onychomycosis has demonstrated a low efficacy rate ranging from 5% to 12%.

Company | Platform Technology | Anti-infectives | Vaccines | Careers | News

© NanoBio® Corporation 2008
NanoBio is a registered trademark of NanoBio Corporation.
All other company, brand, and product names are or may be trademarks of their respective holders. Website by Mellon & Associates, LLC.