AOBiome Therapeutics (“AOBiome”), a clinical-stage life sciences company advancing patented microbiome-targeted therapies, today announced clinical findings from Part 1 of a Phase 1b/2a clinical trial of the Company’s first-in-class Ammonia Oxidizing Bacteria (AOB) product candidate for intranasal delivery. AOBiome’s candidate is a single strain of beneficial AOB, Nitrosomonas eutropha, that converts naturally occurring ammonia to nitric oxide, a signaling molecule well-known to regulate inflammation and vasodilation. In Part 1 of the double-blind, multi-dose, vehicle-controlled Phase 1b/2a trial, AOBiome’s candidate demonstrated promising safety and tolerability when delivered intranasally to healthy volunteers (N=24, randomized 1:1:1 high dose AOB, low dose, and vehicle) over a period of two weeks:
- All adverse events were mild in severity, none of which were considered to be related to the study drug. Additionally, there were no serious adverse events and no discontinuations.
- There were no infectious or inflammatory complications nor local/systemic adverse events related to study drug and no changes in nasal patency, anatomy, or architecture.
Based on these promising results, AOBiome announced that it has initiated Part 2 of its Phase 1b/2a trial to assess preliminary efficacy in subjects with seasonal allergic rhinitis (SAR).
“We are thrilled to announce these latest clinical results, which further underscore the consistently compelling safety findings for our AOB candidate across modalities, including topical and now intranasal delivery,” said Todd Krueger, President and Chief Executive Officer of AOBiome. “We believe our intranasal approach has a number of potential applications beyond rhinitis, including migraines.”
Mr. Krueger continued, “Achievement of this milestone also signals AOBiome’s leadership in translating its novel microbiome-related science into rigorous clinical programs with relevance to human health and disease. We believe we are at the forefront of this rapidly evolving field, and we will continue to drive earlier-stage discoveries across multiple platforms, applying our expertise in systems chemistry and next-generation sequencing technologies to understanding the role and therapeutic benefits of the human microbiome.”
About the Phase 1b/2a Trial
AOBiome’s Phase 1b/2a clinical trial of their AOB product candidate is a randomized, multi-dose, 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.
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. Once deployed, AOB produce 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.