Ann Arbor, Mich. -- A new topical lotion that penetrates the skin deeply enough to target and eliminate serious skin infections, but without being systemically absorbed, has shown a high degree of safety and tolerability in patients with onychomycosis, or toenail fungus, a new study has shown.
"Results of the phase 1 clinical trial are important to the fields of dermatology and infectious diseases because currently approved systemic medications for onychomycosis carry serious risks of cardiac and liver toxicity," said James Baker, MD, chief science officer and founder of NanoBio Corporation in Ann Arbor, Mich.
The phase 1 data for the new lotion, NB-002, were presented at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting Sept. 17 -20, 2007, in Chicago. "At present, the vast majority of people with onychomycosis are untreated as a result of concerns for the serious toxicities associated with the available oral medications," said Baker, whose team developed the lotion. "Our safety data, combined with early information from the ongoing phase 2 trial, indicate that NB-002 is potentially the first treatment for onychomycosis that is highly efficacious and very safe." NanoBio Corporation is a spin-off from the University of Michigan. The company develops novel anti-infective products and mucosal vaccines to treat or prevent a wide range of infections, from cold sores and toenail fungus to influenza and hepatitis B. Its lead products are NB-001 to treat herpes labialis and NB-002 to treat onychomycosis.
NB-002 is a topical oil-in-water nanoemulsion combined with an antimicrobial agent commonly used in oral products to treat gingivitis and other conditions of the mouth and throat. The nanoemulsion undergoes a high-energy process to shrink or "nano-size" the particles so they are small enough to enter the skin through pores and hair follicles but too large to penetrate the tight junctions of the epithelium.
As a result, NB-002 is not systemically absorbed, as the phase 1 study has demonstrated. In the study, 20 subjects with advanced onychomycosis were randomized to receive two strengths of NB-002. Treatments were applied twice daily for 28 days to both affected and unaffected toenails and a small area of surrounding skin. Blood samples were collected periodically to determine if the drug was absorbed systemically.
Results showed the drug was below the quantifiable limit of systemic absorption for all subjects throughout the study period. Additionally, the trial showed that, unlike the current treatments for onychomycosis, NB-002 had no safety or dermal irritation concerns.
Results of a phase 2 clinical trial for onychomycosis are expected in early 2008.
In addition to its topical agents, NanoBio is developing a rich pipeline of needle-free vaccines based on using the same oil-in-water emulsion technology as an adjuvant. Mucosal vaccines against influenza and hepatitis are scheduled for human testing beginning next year, while an anthrax vaccine has demonstrated safety and strong efficacy in animal studies.
NanoBio Corporation is a privately held biopharmaceutical company focused on developing and commercializing anti-infective products and mucosal vaccines derived from its patented NanoStat technology platform. The company's lead product candidates are treatments for herpes labialis (cold sores), onychomycosis (nail fungus), methicillin-resistant Staphylococcus aureus (MRSA) and mucosal vaccines for influenza and hepatitis B. The company's headquarters and laboratory facilities are located in Ann Arbor, Mich.