May 23 2007
NanoBio Corporation today announced positive safety data from its Phase 1 clinical study of NB-002, the company's drug candidate currently in a Phase 2 clinical trial for the topical treatment of onychomycosis.
The Phase 1 clinical 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 1, 3, 7, 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 adverse events in any of the subjects treated. In addition, plasma drug levels were below the limit of detection (1 ng/mL) at all time points. 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 2 clinical study of NB-002 was initiated by NanoBio in the first quarter of 2007.
James R. Baker, MD, NanoBio's Chairman of the Board and Chief Science Officer, commented, "A unique aspect of products derived from the company's NanoStat(TM) 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 1 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."
A randomized, double-blinded, placebo-controlled Phase 2 clinical study is currently being conducted by NanoBio to evaluate the efficacy and safety of three-dose regimens of NB-002 in the treatment of distal subungual onychomycosis. One thousand potential patients are being recruited in order to enroll 400 subjects at 22 sites in the United States and Canada. An interim analysis of planimetry data is planned for December 2007 after 160 of the subjects have completed 24 weeks of treatment. A final analysis of planimetry and complete cure data is anticipated in the second quarter of 2008 after all subjects have completed 42 weeks of treatment. Patient enrollment for the study is currently ahead of schedule.
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. In the US, onychomycosis affects 25% of adults, including 40% of those over 50 years of age. The global market for onychomycosis treatments is anticipated to grow to $3.6 billion by 2010. 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%.
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