AOBiome 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.