Accelerated Healing of Diabetic Ulcer Data Presented

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Accelerated Healing of Diabetic Ulcer Data Presented

20 Jun 2014, Cleveland, OH
AOBiome Reports Preclinical Proof-of-Concept Data Supporting Ammonia Oxidizing Bacteria Use to Accelerate Diabetic Ulcer Healing Studies Presented at Nitric Oxide Society Biennial Meeting

AOBiome, LLC reported today preclinical data demonstrating the potential of its proprietary strain of ammonia-oxidizing bacteria (AOB) to accelerate healing of diabetic ulcers. Separately, the company also presented laboratory studies demonstrating the ability of the same strain to reduce levels of several pathogenic bacteria commonly found on the skin and infected wounds. The studies were presented at the 8th International Conference on the Biology, Chemistry and Therapeutic Application of Nitric Oxide, held in Cleveland, OH.

Based on these and other studies, AOBiome plans to submit an IND in 2015 to begin clinical trials with an AOB-based therapy for the treatment of diabetic ulcers.

“Therapy with AOB represents a new treatment paradigm based on advances in understanding the skin microbiome,” said Spiros Jamas, ScD, CEO of AOBiome and an author on the studies. “These studies provide initial proof-of-concept that topical application of AOB may restore the natural balance of beneficial microbial species on the skin and has the potential of providing therapeutic benefits in the treatment of diabetic ulcers.” Dr. Jamas noted that foot ulcers remain a common and serious complication of diabetes, affecting approximately 15 percent of diabetic patients and leading to approximately 80,000 amputations annually in the US alone.

AOB are ubiquitous microorganisms that metabolize ammonia and urea into nitrite and nitric oxide. AOBiome’s approach builds on these distinctive microbial properties and the discovery by the company’s scientific founder, David Whitlock, that AOB function as commensals (symbionts) on human skin by metabolizing the ammonia and urea in sweat. AOB are no longer commonly found on human skin as they are eliminated by most soaps. The company’s therapeutics in development are based on its proprietary strain of Nitrosomonas eutropha.

Study Details
In the wound healing study, reported in an oral presentation, the researchers evaluated the capacity of the N. eutropha strain to accelerate wound closure in diabetic (db/db) mice. Three groups of eight mice were pre-treated with N. eutropha supplemented with ammonium chloride and one group with vehicle alone. Following wounding, the mice received one of three doses of N. eutropha or vehicle daily for 14 days. The group receiving the highest doses of AOB showed a significant improvement in wound closure, a statistically significant difference from the group receiving the vehicle. No adverse events with the treatment were observed. A subsequent study with no pre-treatment, produced similar results.

The study on the anti-infective properties of AOB, presented in a poster session, evaluated the capacity of AOBiome’s strain to reduce the survival of pathogenic bacteria in co-culture in vitro. When ammonia was added to the culture, nitrite generation, along with acidification induced by AOB, resulted in an up to 1,000-fold decrease in levels of five pathogenic bacteria found on skin or infected wounds: Pseudomonas aeruginosa, Methicillin-resistant Staphylococcus aureus (MRSA), Streptococcus pyogenes, Acinetobacter baumannii, and Propionibacterium acnes.

In addition to Dr. Jamas, other authors on both studies included, Ioannis Gryllos, PhD, Larry Weiss, MD, and David Whitlock from AOBiome, and Neeraja Vajrala, PhD, and Luis Sayavedra-Soto, PhD, from the Department Botany and Plant Biology at Oregon State University.

About AOBiome
AOBiome LLC is developing a transformative, new class of skin products based on ammonia-oxidizing bacteria (AOB). The company’s products are designed to restore the natural balance of skin microbes that have been lost due to modern living practices, including use of soaps, and shampoos. AOB are ubiquitous bacteria that oxidize ammonia and urea, two components in sweat. The company is introducing a cosmetic product, AO+™ Refreshing Cosmetic Mist, to improve skin look and feel. Separately, AOBiome plans to file an Investigational New Drug (IND) application with the FDA to pursue different formulations of AOB in therapeutic indications including acne, eczema, and diabetic ulcers.

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