AOBiome Commences Patient Enrollment in Phase 1b/2a Clinical Trial of Ammonia Oxidizing Bacteria (AOB) for the Treatment of Seasonal Allergic Rhinitis

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AOBiome Commences Patient Enrollment in Phase 1b/2a Clinical Trial of Ammonia Oxidizing Bacteria (AOB) for the Treatment of Seasonal Allergic Rhinitis


First-in-Class Therapy Enables Intranasal Delivery of Nitric Oxide

Cambridge, MA, October 3, 2017
AOBiome, a clinical-stage life sciences company advancing patented microbiome-targeted therapies for systemic and local inflammatory conditions, today announced the initiation of patient enrollment in AOBiome's Phase 1b/2a clinical trial of the Company's Ammonia Oxidizing Bacteria (AOB) product candidate, for the treatment of seasonal allergic rhinitis (SAR). The initiation of enrollment represents a first-in-class, intranasal formulation incorporating a single strain of beneficial ammonia-oxidizing bacteria (AOB), Nitrosomonas eutropha. Once administered, the AOB convert naturally occurring ammonia to nitric oxide, a signaling molecule well-known to regulate inflammation and vasodilation.

"AOBiome continues its leadership in innovation with the initiation of what we believe is the first FDA-supported clinical study to test intranasal application of a microbiome-targeted therapy," said Todd Krueger, President of AOBiome. "The SAR trial is designed to provide early evidence for the potential efficacy of our approach as a prophylactic treatment for those who suffer from seasonal allergies. In addition, we look forward to establishing safety and tolerability with another route of delivery, which will allow us to pursue a broader range of diseases that are amenable to intranasal delivery." To date, AOBiome's AOB formulations have been tested in more than 270 individuals, with no serious adverse events and no difference in adverse events between treatment and vehicle groups.

AOBiome's Phase 1b/2a clinical trial of their AOB product candidate is a randomized, double-blind, vehicle-controlled study designed to evaluate safety and tolerability in up to 24 healthy volunteers and preliminary efficacy as a prophylaxis therapy in up to 42 individuals with a history of SAR due to ragweed pollen. Additional information about AOBiome's Phase 1b/2a study in SAR may be found at ClinicalTrials.gov, using Identifier NCT: NCT03290248.

"Current treatments for SAR are frequently associated with local and/or systemic adverse effects that can cause many patients to pursue alternative strategies for control of their symptoms," stated Chief Medical Officer, Larry Weiss, MD. "Our platform seeks to address SAR through a novel approach, adjusting human commensal bacteria in the nasal microbiome to rebalance inflammatory processes underlying disease. We look forward to sharing the progress of our clinical program utilizing intranasal delivery."

About Ammonia Oxidizing Bacteria (AOB) AOBiome's AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. The platform is designed to repopulate the skin or nasal microbiome with AOB normally found on the body. Once deployed, AOB convert ammonia to nitrite, which is known to have antibacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation.

About Seasonal Allergic Rhinitis Seasonal allergic rhinitis (SAR) is an inflammatory disease in which exposure to outdoor allergens, such as plant pollen or mold spores, results in inflammation of the nasal passages. Individuals with allergic rhinitis may experience symptoms including sneezing, runny nose, nasal itch, and nasal congestion, which can have a significant impact on patients depending on the degree of severity. According to the Centers for Disease Control and Prevention, SAR affects nearly 8% of the U.S. population (see reference for 2015 statistics). Unmet needs in SAR are substantial, particularly in regard to achieving a balance between potential side effects and adequate symptom control.

About AOBiome AOBiome is a Boston-based life sciences company focused on transforming human health by developing microbiome-targeted therapies for local and systemic inflammatory conditions. Founded in 2013 by Patients Like Me founder Jamie Heywood and MIT Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of novel therapeutic candidates for systemic, nasal, and local conditions. AOBiome's lead programs include two mid-stage clinical trials: a Phase 2b study to treat patients with acne vulgaris and a Phase 2 trial to reduce elevated blood pressure. Additionally, the Company is advancing a Phase 1b/2a clinical trial in allergic rhinitis, as well as earlier-stage preclinical programs targeting diverse inflammatory indications. Learn more at AOBiome.com.

Contacts:

For Media Inquiries Justin Jackson
212-213-0006, ext. 327
jjackson@burnsmc.com




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