On March 31, 2006, Nitric Bio received its initial funding and has raised a total of $14M. The primary investors are Quaker BioVentures, New Spring Capital, Cardinal Health (now Carefusion, a new company spun off from Cardinal Health) and Virtucon Inc. The company licensed the patents for its core nitric oxide gas technology on an exclusive basis from Cardinal health, and a company related to Virtucon. The original purpose of the company was to develop pharmaceutical applications of nitric oxide gas.
Nitric Oxide
Nitric Oxide (NO) is a molecule of increasing interest in the medical world. NO is best known today as a potent vasodilator and is the end product of a number of drugs that collectively represented more than $55 Billion in 2005 pharmaceutical sales. NO has a number of other important physiological activities that are being studied in the academic medical community. Some of the properties identified in the literature concerning NO are:
· Broad spectrum anti-bacterial agent
· Anti-microbial activity against fungi
· Anti-microbial activity against parasites and viruses
· Activity against biofilms
· Activity against drug-resistant strains
· Anti-inflammatory actions
· Regulation of MMPs (including collagenase)
· Chemo-attractant for certain cell types
· Neurotransmitter
· Involvement in apoptosis
· Pro-angiogenic
· Increases blood flow
Since NO is a regulatory molecule, different concentrations can have different effects. For example, at low concentrations NO is pro-inflammatory, while at higher concentrations it is anti-inflammatory. A significant challenge to obtaining the desired effect of NO is getting the correct concentrations of the drug for a specific exposure. The Nitric Bio patent estate covers the use of topically-applied NO gas for conditions on the human skin. This application of gas allows for precise amounts of gas to be used to achieve the desired effect.
Nitric Bio has a primary goal for the use of NO as an anti-infective, including:
· Commercialization of NO products for the treatment of topical fungal infections
· Commercialization of NO products for the treatment and prevention of bacterial infections, including MRSA and other resistant organisms
The company is currently finishing Phase 2 clinical trials for the use of NO in the treatment of moderate-to-severe tinea pedis (athlete’s foot). Over 3 million patients visited medical professionals in 2007 for tinea pedis, and there were over 37 million OTC products sold to patients to help resolve symptoms.
Iontophoresis
In November, 2009, Nitric Bio completed a transaction to purchase the intellectual property and rights to clinical development work for the use of iontophoresis to treat dermatologic conditions. Iontophoresis is the use of electric current to enhance the penetration of drugs through various surfaces on the human body, mainly skin and nails, allows for the delivery of many times the levels of drug seen with passive diffusion.
Two of the clinical programs acquired by Nitric Bio are currently in human clinical trials. One of the products is for the treatment of onychomycosis (toenail fungus). This involves the iontophoretic delivery of a proprietary formulation of terbinafine, a drug that has been proven to be effective to treat onychomycosis but must be taken orally for several months and carries the risk of several side effects, including liver toxicity. A Phase 1 clinical trial has been completed, and Nitric Bio will initiate a Phase 2 trial in Q1 2010. The market for products to treat onychomycosis was over $2 billion in 2007, with less than 50% of the 35 million patients estimated to have onychomycosis seeking professional treatment.
The other product acquired by the company is for the treatment of oral herpes (cold sores). Iontophoresis is used to deliver large amounts of a proven cold sore drug, acyclovir, to the site of infection. Phase 2a clinical trials have demonstrated that the product is significantly more effective than products currently approved to treat oral herpes. Nitric Bio will seek a partner to continue the development of this product.
Iontophoresis can be used to improve drug delivery and treatment outcomes in a variety of different disease states. These include:
· Warts
· Acne
· Psoriasis
· Actinic keratoses
