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Novan’s Nitricil™ Technology Shows Efficacy Against Multidrug Resistant Superbugs

Comparative Effectiveness Data in Preclinical In Vivo Models to be Presented at the 2014 Military Health System Research Symposium

DURHAM, N.C.--(BUSINESS WIRE)--Novan Therapeutics, a clinical-stage biotech company focused on advancing nitric oxide therapies, announced today 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 will be presented this evening 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.

“Antimicrobial Efficacy of a Nitric-Oxide Releasing Drug Candidate in vitro and in vivo Utilizing an Infected Porcine Partial Thickness Burn Wound Model”

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,” commented 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,” stated 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.”

MHSRS-868: “Antimicrobial Efficacy of a Nitric-Oxide Releasing Drug Candidate in vitro and in vivo Utilizing an Infected Porcine Partial Thickness Burn Wound Model” K. Coggan, J. Gil, J. Valdes, R. True, M. Solis, S. Davis, and N. Stasko

Presenter: Kimberly Coggan, PhD, Molecular Microbiologist, Novan Therapeutics

Session Date, Time and Location: Tuesday, August 19, 2014, 6:00 p.m. – 8:00 p.m. EDT, Board #21

This work is supported by the US Army Medical Research and Materiel Command under Contract No. W81XWH-11-C-0029.

MHSRS-699: “Comparative Evaluation of Commonly Used Antimicrobial Wound Dressings and Nitric Oxide Treatment of Infected and Non-Infected Full-Thickness Wounds on Swine (Sus scrofa)” R. Brodnick, J. Barnhill, L. Pierce, K. Matsumoto, M. Lustik, S. VanHorn, C. Belnap, and N. Stasko

Presenter: Maj. Robert Brodnick, Tripler Army Medical Center, Department of Clinical Investigation

Session Date, Time and Location: Tuesday, August 19, 2014, 6:00 p.m. – 8:00 p.m. EDT, Board #20

The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. In conducting research using animals, the investigator(s) adhered to the Animal Welfare Act Regulations and other Federal statutes relating to animals and experiments involving animals and the principles set forth in the current version of the Guide for Care and Use of Laboratory Animals, National Research Council.

About Novan, Inc.

Novan Therapeutics is a privately-held, clinical stage biotech company focused on advancing nitric oxide therapies. Nitric oxide, one of the most studied molecules in human physiology, has been shown to exhibit antimicrobial activity, promote vasodilation, regulate inflammation, stimulate tissue repair, and eradicate cancer cells. Novan’s core technologies solve the previous delivery issues with nitric oxide by stably storing the gaseous species on macromolecules that result in a diverse pipeline of “timed-release” nitric oxide-releasing new chemical entities. The Company's proprietary platform technology enables drugable nitric oxide in a variety of dosage forms.

This press release contains forward-looking statements involving risks and uncertainties, both known and unknown, that may cause actual results to differ materially from those statements. Actual results may differ materially due to a number of factors, including, but not limited to, risks associated with pharmaceutical development, clinical trials that cost more, are less effective and take longer to complete than expected, raw materials and drug supply, changes in regulatory requirements, competition, and financing.

To learn more about Novan Therapeutics, please visit www.novantherapeutics.com.

Contacts

Novan Therapeutics
Rachel Shockley, 919-354-2993
rshockley@novantherapeutics.com