Positive Clinical Safety Results for AOBiome's Microbiome-Targeted Therapy for Intranasal Delivery

March 21, 2018

AOBiome Therapeutics 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.

Specifics included:

    - 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."

AOBiome describes its approach as being unlike most other bacterial therapies in that they are deploying a single strain of bacteria in various dosing strengths which allows for a greatly streamlined manufacturing process. In addition, by leveraging expertise in manufacturing our consumer products as well as the outstanding safety profile of their bacteria they have been able to focus on efficacy in early stage trials.

AOBiome's theory is that current hygiene practices have stripped ammonia-oxidizing bacteria (AOB) from the modern biome. Their products are designed to restore the bacteria. AOBiome also owns the Mother Dirt branded line of consumer biome-friendly products targeted at restoring and maintaining the delicate balance of the skin biome.

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