US-based life sciences firm AOBiome has started enrolling patients in a Phase Ib/IIa clinical trial of its ammonia oxidising bacteria (AOB) product candidate to treat seasonal allergic rhinitis (SAR).
AOB platform is a patented, proprietary, topical and intranasal formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha. It is designed to repopulate the skin or nasal microbiome with AOB normally found on the body.
Once administered, AOB converts ammonia to nitrite, which is known to have antibacterial properties, and to nitric oxide, a signalling molecule found to regulate inflammation and vasodilation.
AOBiome president Todd Krueger said: "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.
"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."
The company noted that its AOB formulations have so far been tested in more than 270 people, with no serious consequences and no difference in adverse events between treatment and vehicle groups.
The randomised, double-blind, vehicle-controlled Phase Ib/IIa trial is designed to evaluate safety and tolerability of the company's AOB product candidate in up to 24 healthy volunteers and preliminary efficacy as a prophylaxis therapy in 42 people with a history of SAR caused by ragweed pollen.
AOBiome chief medical officer Larry Weiss said: "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.
"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 utilising intranasal delivery."
Image: Illustration depicting inflammation associated with allergic rhinitis. Photo: courtesy of BruceBlaus.