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NB Therapeutics is investigating and evaluating a number of additional dermatology indications and drugs that might benefit from its proprietary iontophoresis or Nitric Oxide delivery technology.  These include iontophoresis for the treatment of Acne and Psoraisis, as well as Nitric Oxide for the treatment of Tinea Pedis and Skin and Soft Tissue Infections.

Tinea Pedis

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Our Nitric Oxide Platform

There are estimated to be at least 15 million patients with tinea pedis, commonly known as athlete’s foot, although estimates range as high as 30 million. Of that number, approximately 2.5 million patients visited a doctor in 2007 for treatment. Of the 2.5 million patients, 63% of patients were treated by podiatrists, 8% were treated by dermatologists, and the rest by primary care physicians or other specialists. Most patients who seek treatment from a physician have tried and failed on OTC treatments.

Fungal infections of the feet cause  mild to moderate discomfort and embarrassment for many patients. However, serious medical complications may arise when these infections occur in diabetics and other immunocompromised patients.

NB Therapeutics has completed Phase 2b studies in tinea pedis using the application of nitric oxide gas and has demonstrated that the product is both safe and effective in only 30 minutes of treatment.

Skin and Soft Tissue Infections

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Nitric Oxide PlatformBacterial Skin and Soft Tissue Infections (SSTI) are a rapidly growing problem, with ever-increasing morbidity, due to the growing incidence of multi-drug resistant bacteria. Over 22 million SSTIs were reported in 2009. In the US, there were 15.6 million ambulatory visits and over 6.5 million non-ambulatory visits for SSTIs, an increase of more than 100% from 2001.

NB Therapeutics is developing a treatment that has the profile to become a first-line treatment for all skin and soft tissue infections, whether caused by bacteria, fungus, or parasites. NB Therapeutics’s novel approach uses a variation of the body’s normal defense against pathogens, which delivers fast action and universal spectrum coverage, at a dose that is lethal to all bacteria and fungus but is fully tolerated by human cells.

NB Therapeutics uses topical nitric oxide gas (gNO) that flows over the treatment site for a 30 minute application. Nitric oxide’s antimicrobial activity has been extensively documented in the literature. The use of a gas is a simple, local and elegant solution.  Since the half-life of gNO in contact with tissue is only 6 seconds, there are no systemic effects or toxicities when applied topically to lesions

NB Therapeutics believes that the greatest market opportunity for a gNO product is in the bacterial SSTI market. The company has performed depth of penetration studies and preliminary human proof-of-principle studies in order to design appropriate Phase 2a studies. NB Therapeutics believes that the initial uses for gNO in the bacterial SSTI market could be in areas such as infections associated with burns and grafts. These are high-need markets where infections by multiple microorganisms are rampant and current treatments are inadequate.

Acne

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Iontophoresis PlatformAcne is the most common skin condition in the United States, with between 40 to 50 million Americans suffering from the disease.  Acne can occur at any age, but most people who have the disease are teenagers and young adults. It is estimated that 85% of U.S. teenagers will have an outbreak of acne each year. 

Acne is characterized by areas of skin with seborrhea (scaly red skin), comedones (blackheads and whiteheads), papules (pinheads), pustules (pimples), nodules (large papules) and possibly scarring.  Acne typically affects skin with the densest population of sebaceous follicles; these areas include the face, the upper part of the chest and the back. Severe acne is inflammatory, but acne can also manifest in non-inflammatory forms.  The lesions are caused by changes in pilosebaceous units, skin structures consisting of a hair follicle and the associated sebaceous gland.

Acne is treated with a number of topical and oral drugs.  Topical products, such as clindamycin and benzoyl peroxide, are sometimes not effective in penetrating through the epidermal barrier, thus limiting efficacy.  Oral medications, such as the tetracycline class, can cause systemic side effects, thus limiting their ability to be taken long-term. 

NB Therapeutics is exploring ways to deliver medication more effectively to the site of infection but without systemic absorption through the use of its proprietary iontophoresis technology.

Psoriasis

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Iontophoresis PlatformNearly 7.5 million people in the United States have psoriasis and about 150,000 new cases are diagnosed each year. Studies indicate that psoriasis develops about equally in males and females. Research also shows that Caucasians develop psoriasis more frequently than other races. A study conducted in the United States found the prevalence was 2.5% in Caucasians and 1.3% in African Americans.   One of the risk factors for psoriasis is a family history of the disease.  Psoriasis can begin at any time, from infancy through old age. However, most people who suffer from the condition first see psoriasis between 15 and 30 years of age, with about 75% developing psoriasis before they turn 40. Another common time for psoriasis to begin is between 50 and 60 years of age.

Psoriasis can be treated by topical therapy, phototherapy or systemic therapy.  Topical treatment can include steroids or Vitamin-D analogues, but these can be messy and may stain clothing and skin. Phototherapy can require 2 to 5 visits each week to a dermatologist’s office or psoriasis clinic for a period of several weeks. Systemic medications include injectable immune modulators.  These can be very effective but can have side effects and must be combined or rotated with other therapies to maximize effectiveness and minimize side effects.

 The NB Therapeutics iontophoresis technology has the potential to deliver topical therapies that cross the skin barrier and hence directly treat the site of disease. This approach has the potential to improve efficacy, while lowering the amount of drug necessary and thereby significantly reducing side effects.