NanoBio Initiates Phase 2 Clinical Trial for Treatment of Onychomycosis
NanoBio(R) Corporation, a biopharmaceutical company developing novel products for the treatment and prevention of serious infections, today announced that the Company has begun enrolling patients in its Phase 2 study of NB-002. NB-002 is a drug candidate for the topical treatment of onychomycosis, a fungal infection of the fingernail and toenail. Currently, almost $2 billion a year is spent on treatments for this disease.
James R. Baker, MD, NanoBio's Chairman of the Board and Chief Science Officer, commented, "At present, the vast majority of people with onychomycosis are untreated as a result of the serious toxicities associated with the available oral medications. NB-002 is a topical therapy for onychomycosis with a remarkable safety profile, as evidenced in several prior animal studies and clinical trials. In launching this Phase 2 trial for NB- 002, we take the next step towards bringing a safe and effective topical treatment to market."
The Phase 2 trial is a randomized, double-blind, placebo-controlled study at 25 sites in North America, where 1,000 potential patients are being recruited.
Dr. Baker added, "We are able to safely treat onychomycosis using topical doses of NB-002 that are 2,000 to 3,000 times higher than those necessary to kill fungi in culture. NB-002 works at the nail bed - as do systemic products - and therefore kills nail fungus at the site of the infection. We expect many of the estimated 32 million people with untreated onychomycosis will one day benefit from using NB-002 as a safe and efficacious approach to eradicate this disease."
Previous Phase 1 Study for NB-002
NanoBio recently completed a Phase 1 study of NB-002. In this study, subjects received twice-daily treatments for 28 days with the highest projected treatment dose of NB-002. Following the study there was no evidence of dermal irritation, and the treatments were well tolerated by all subjects.
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 United States, 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 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%.