Novan Therapeutics, a clinical-stage biotech company focused on advancing nitric oxide therapies, announced that the company’s Nitricil platform technology has been shown to be efficacious against several of the most multi-drug resistant pathogens plaguing civilian and military health care providers across the globe. The antimicrobial results from two preclinical studies were presented at the 2014 Military Health System Research Symposium (MHSRS), taking place in Fort Lauderdale, Florida.
Among key findings, Novan’s nitric oxide-releasing technology was shown to be effective against Acinetobacter baumannii, a gram-negative bacterium resistant to nearly all antibiotics, including carbapenems (often considered antibiotics of last resort). A. baumannii causes pneumonia, urinary tract infection, and combat- and trauma-related wound infections.
Based on these results and additional progress of the preclinical program, Novan plans to initiate clinical development for the treatment of chronic wound infections resulting from multi-drug resistant bacteria in the first half of 2015.
“Novan’s results show efficacy against the three bugs tested in an infected wound model, including Acinetobacter, as well as Candida and Methicillin-resistant Staphylococcus aureus. These microorganisms are serious threats according to the CDC’s most recent published report on superbugs, and collectively account for up to 90,000 cases and thousands of deaths each year in the United States,” said Major Robert Brodnick, department of clinical investigation, Tripler Army Medical Center. “In our study at Tripler, topical nitric oxide reduced S. aureus colonization more effectively than commercially available wound care products and it was the only treatment to show a significant enhancement of the rate of wound healing compared to standard of care.”
Nitric oxide, a key component of the innate immune response, has been well-documented to be effective both in vitro and in vivo against many of the “qualifying pathogens” outlined in the Generating Antibiotic Incentives Now (GAIN) provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA). Novan’s approach for the treatment of multi-drug resistant infection involves stably storing nitric oxide with its Nitricil technology that can then be applied to mimic the immune response in a site-specific, localized fashion.
“Nitricil is bactericidal, and not simply bacteriostatic, which means that it kills the bugs instead of just inhibiting growth,” said Dr. Nathan Stasko, Novan president and co-founder. “The mechanism of action is key. Most antibiotics target specific bugs and often elicit drug-specific resistance. We believe our nitric oxide approach surmounts resistance and induces broad nitrosative and oxidative stress, which results in efficacy against a diverse array of microorganisms.”
