There is a growing recognition of the need for new therapeutic approaches for the treatment of bacterial infections in response to the emergence of antibiotic resistance. Topically applied nitric oxide (NO) is a potentially useful preventive and therapeutic strategy against acne and superficial skin infections, including methicillin-resistant Staphylococcus aureus (MRSA), the newly emerging vancomycin-resistant Staphylococcus aureus and Acinetobacter baumannii.
The Company's Nitric Oxide (NO) containing nanoparticles are being developed as a microbicidal wound dressing for infected wounds and as an antiseptic, preventative treatment for new wounds and surgical sites. The product candidate is expected to be effective against all known bacteria including MRSA, vancomycin resistant SA and other antibiotic resistant bacteria. Importantly, it is unlikely that bacteria will evolve resistance to NO.
There is a multi-billion dollar market opportunity and the need for innovation is pressing. For example, Staphylococcus aureus (SA) is responsible for the majority of superficial and invasive skin infections, resulting in more than 11 million outpatient/emergency room visits and 464,000 hospital admissions annually in the US. SA clinical strains continue to evolve resistance to our most potent antibiotics. Today less than 5% of clinical isolates remain sensitive to penicillin. In the 1980s, methicillin-resistant SA (MRSA) emerged as a prominent hospital based infection stimulating an increase in the use of vancomycin. A 1997 survey by the Center for Disease Control (CDC) showed the proportion of methicillin-resistant isolates with sensitivity only to vancomycin increased from 22.8% in 1987 to 56.2% in 1997.
Initial studies in MRSA infected murine wound models have resulted in significant reduction in infection, faster healing and better collagen deposition and collagen retention at the wound site after topical application of a simple water suspension of the NO containing nanoparticles.
NO is recognized to play an important role in immunity and the wound healing process. A sustained local delivery of NO as provided for with this product has broad implications for its potential indications. The product could be developed for the treatment of numerous types of wounds, such as surgical sites, trauma, burns and decubiti. Furthermore, wound healing complicated by common comorbidities, such as obesity, diabetes, atopic dermatitis and peripheral vascular disease may benefit from NO based therapy. For example, diabetics are prone to chronic leg and foot ulcerations caused by abnormalities in NO production resulting in both neurological and vascular complications. A product that can provide for sustained delivery of therapeutic levels of NO could be beneficial.
Initial clinical studies will focus on the treatment of wounds infected with antibiotic resistant organisms, addressing a clear unmet need. In addition, grants will be pursued with the Department of Defense to develop a battlefield compatible disinfectant dressing.