SOURCE: NB Therapeutics

January 05, 2011 15:12 ET

NB Therapeutics Completes Enrollment in Phase 2 Onychomycosis Study

Company Changes Name to NB Therapeutics From Nitric Bio

BRISTOL, PA--(Marketwire - January 5, 2011) - NB Therapeutics, Inc., a pharmaceutical development company specializing in dermatology, podiatry and anti-infective products, today announced completion of patient enrollment in its Phase 2 clinical trial evaluating NBT-320, which is the use of iontophoresis and a novel formulation of terbinafine for the treatment of onychomycosis, commonly known as toenail fungus. Separately, the company announced that it had changed its name from Nitric BioTherapeutics to NB Therapeutics.

NB Therapeutics' Phase 2 onychomycosis study enrolled 165 patients at nine sites in the US and Canada. The study is evaluating the safety and efficacy of using iontophoresis to deliver a proprietary, ionized formulation of terbinafine to treat moderate onychomycosis. NB Therapeutics' patented formulation of terbinafine has been specially designed to penetrate the toenail and nail bed when applied topically with a low-level, painless electric current. Preliminary clinical results for NBT-320 will be available in Q1 2011, with final results available in Q4 2011.

Onychomycosis is a chronic fungal infection affecting the toenails and fingernails of over 35 million patients in the U.S. Current therapeutic options are limited due to potential liver toxicity, drug-drug interactions, and low efficacy. Oral terbinafine (Lamisil®) is the most effective drug approved by the U.S. Food and Drug Administration for the treatment of onychomycosis; however, it requires daily administration for three months, as well as liver function testing throughout the course of treatment. The global market for onychomycosis treatments was estimated to be $2 billion in 2010. 

"With iontophoresis, we can deliver ionized terbinafine directly to the nail at levels almost 2,000 times greater than oral terbinafine, with none of the oral drug's systemic side effects," commented Frank J. McCaney, NB Therapeutics' President and CEO. "The ionized terbinafine is applied directly to the infected nail in one or two 20-minute, in-office treatments, ensuring patient compliance. When our Phase 2 results are available later in 2011, we anticipate demonstrating that our onychomycosis treatment can significantly improve outcomes for the 35 million people in the US suffering from this disease." 

About NB Therapeutics, Inc.

NB Therapeutics is a private pharmaceutical company developing novel and proprietary products to address unmet medical needs in the dermatology and podiatry markets. NB Therapeutics has two technology platforms: iontophoresis and nitric oxide gas. Through these platforms, NB Therapeutics seeks to address the inherent challenges of drug delivery for diseases of the skin and nails. The company's lead product, NBT-320, is a patented, ionized formulation of terbinafine which is delivered to the nail and nail bed through iontophoresis for the treatment of onychomycosis. NB Therapeutics is located in Bristol, PA. More information on the company can be found at www.nitricbio.com.

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