NanoBio sees good Ph I for topical onychomycosis agent

NanoBio Corp, a US biopharmaceutical company developing novel products for the treatment and prevention of serious infections, has announced positive safety data from its Phase I clinical study of NB-002, the company's drug candidate currently in a Phase II evaluation for the topical treatment of onychomycosis.

The Phase I study was completed in January 2007 and involved 20 subjects who received twice-daily treatments of NB-002 (0.25% or 0.5%) for 28 days. Subjects were examined on days one, three, seven, 14, 28 and 58 for adverse events, dermal irritation and pharmacokinetic sampling. There were no drug-related adverse events, serious adverse events or discontinuations due to these in any of the subjects treated. In addition, plasma drug levels were below the limit of detection (1ng/mL) at all time points. NanoBio said that, "based on the remarkable safety profile demonstrated in this clinical study, as well as other previously-conducted clinical and toxicology studies, a 42-week double-blinded Phase II clinical study of NB-002 was initiated by NanoBio in the first quarter of 2007.

James Baker, NanoBio's chairman and chief science officer, commented: "a unique aspect of products derived from the company's NanoStat technology is that the treatments are not systemically absorbed and they are selectively toxic to microbes while non-irritating to the skin and mucous membranes. This Phase I safety data further confirms that NB-002 will offer a safe alternative to the currently available systemic products. This is a critical factor for individuals affected by onychomycosis, given approximately 95% of people with this disease remain untreated as a result of the serious toxicities associated with the oral medications on the market."