Pioneering bacterial therapy for the skin. | Pioneering bacterial therapy for the skin

Pioneering bacterial therapy for the skin.

AOBiome LLC is developing first-in-class topical biologics for the treatment of inflammatory skin conditions. We have developed extensive scientific and manufacturing expertise on the use of beneficial ammonia-oxidizing bacteria (AOB). AOB are naturally occurring bacteria that metabolize the ammonia found in sweat, creating both nitrite and nitric oxide, with both anti-inflammatory and anti-infective properties.

The therapeutic potential of nitrite and nitric oxide are widely recognized, although as yet, largely unrealized as delivery, let alone targeted delivery is extremely difficult. The company's proprietary AOB offers the potential of a first-in-class natural delivery system for nitrite and nitric oxide.

Background on the Microbiome
The microbiome is the first new organ to be discovered in over 150 years. The discovery of vast bacterial colonies in the digestive system of a normal human being has led to an explosion of scientific research and understanding. These new insights have made clear that populations of 'good bacteria' play important roles in maintaining health by suppressing pathogenic species and influencing a range of metabolic, neurologic and immune system functions. Shifts in the microbial composition in the gut, for example, have now been linked to human diseases, including inflammatory and autoimmune disorders. An entire industry has arisen around the gut microbiome, including a commitment of $100m's to research, a $B dollar market for probiotic yogurts and supplements, and several bacteria based drugs in late stage trials for diseases like IBS, Crohn's, C. Diff, and other difficult to treat conditions. More recently, identification the skin microbiome has exposed how such bacteria are critical to health. Such an example is the recent discovery of uncontacted civilization that do not employ Western Hygeine products or practices. They have been found to have a diverse skin microbiome that contains AOB's and they have little to no incidence of inflammatory skin disease. Unfortunately, most "Hygienic" products kill off the skin biome. This "cleaning" has contributed to a host of modern skin diseases such as acne, rosacea, psoriasis, and eczema.

AOBiome's Approach
Since AOBiome began operations in 2013, the company has made rapid and significant progress in validating its approach and advancing its product pipeline. We have performed in-vitro studies, in-vivo studies as well as two human studies, the results of which have shown both remarkable safety and have supported the beneficial role of AOB on skin health. In 2014, AO+ Mist was introduced to the market as healthy skin cosmetic on the heals of widely read article which appeared in the New York Times Magazine, "My No-Soap, No Shampoo, Bacteria-Rich Hygiene Experiment," by Julia Scott. With no marketing or claims we have over 3,000 customers for the alpha version of the bacterial mist, with high customer satisfaction and rebuy rate. Customers with self reported skin issues have purchased at twice the average. Such feedback has led to the identification of a wide array of conditions with which consumers have reported positive results. We have used this early information to help prioritize the therapeutic indications that we will pursue.

Therapeutic Programs
AOBiome's therapeutic program is focused initially on adult acne as acne is a model for other inflammatory skin diseases. The company is initiating a Phase 2 dose-ranging clinical trial with its first product candidate, B244, under an IND submitted to the FDA's CBER division. The company is also planning clinical trials to explore the potential of AOB in the treatment of eczema, rosacea, diabetic ulcers, bacterial vaginosis as well as other therapeutic indications.

To protect AOBiome's product portfolio, the company has issued patents covering the topical use of AOB. Additional patents have recently been filed for AOBiome's lead strain, and methods of propagation, formulation, and application to the skin.