AOBiome Therapeutic is a world-leading clinical-stage microbiome company focusing on research and development of therapeutics for inflammatory conditions, central nervous system disorders and other systemic diseases. Our proprietary product candidates harness a single strain of class-defining, auto-regulating Ammonia Oxidizing Bacteria, or AOB, a human commensal with well-understood and well-characterized biochemical properties that are critical to human health. We believe that the application of AOB has the potential to restore critical biological and biochemical processes through the symbiotic relationship between humans and this naturally-existing bacteria to address significant clinical need. As of the Latest Practicable Date, we have six ongoing clinical programs in acne vulgaris, or acne, allergic rhinitis, migraine, atopic dermatitis, or eczema, rosacea and hypertension, and multiple ongoing preclinical programs, including pulmonary and gastrointestinal disorders. Our product candidates were permitted by the FDA to proceed directly to Phase 2 in many indications. We have completed our Phase 2 trial for acne and expect to begin enrolling patients in two Phase 3 studies for this indication in the first half of 2019. Our other five programs are all in Phase 2 development.
We have identified therapeutic opportunities caused by the adverse impact of the modern environment on human physiology. The human body relies on a system of multiple microorganisms, chemistries, and pathways which have evolved with humans for millennia, and that together are essential to human health. When these microorganisms are imbalanced, or dysbiotic, the human body can be more susceptible to disease. Due to the widespread use of surfactants, antimicrobials, antibiotics, and general “sterilization,” these vital microorganisms have been stripped out of the modern human body and the living environment. In parallel, the incidence rates of systemic and inflammatory diseases have risen over the course of modern history. However, populations that live closer to natural environments, without the use of chemicals and the focus on antimicrobials, have been shown to be healthier in many respects. We believe that restoration of the symbiotic relationship between bacteria and human beings will have a profound effect on human health. AOB’s anti-inflammatory and pH-lowering properties, and its ability to reduce levels of pathogenic bacteria such as Propionibacteria acnes and Staphylococcus aureus, coupled with our earlier anecdotal feedback from the Cosmetic Product, led us to undertake our clinical trials described below.
We are using the same active ingredient, B244, a live single strain of Nitrosomonas eutropha, in different potencies and formulations tailored to each of our clinical trials, and we initially targeted inflammatory conditions that are not well served by current therapies either due to lack of efficacy or intolerable side effects. We currently have six programs conducting clinical trials: AOB101 for the treatment of acne; AOB102 for the treatment of eczema and associated pruritus; AOB103 for the treatment of rosacea, AOB201 for allergic rhinitis; AOB202 for migraines and AOB203 for hypertension. In all of our clinical studies, we have observed a very favorable tolerability profile, with no signs of hypersensitivity reactions, inflammatory reactions, localized infections, bacteremia or sepsis or any serious adverse events.
Since AOBs are human commensals, we first made the strategic decision to capitalize on this opportunity to gain access to early customer and product feedback by commercializing AOB-related cosmetic products. Upon launch, we experienced significant customer demand. This demand for the Cosmetic Products enabled us to refine our manufacturing, storage, and packaging capabilities for cosmetic products containing our live single strain bacteria to meet customer demand in commercial quantities. The manufacturing protocols and quality standards that were used for the Cosmetic Products formed the basis for our cGMP manufacturing currently being used to manufacture our clinical supply of our AOB-based product candidates. The license of our Cosmetic Products business to MBX in 2017 allowed us to focus exclusively on our research and development for our therapeutic product candidates.