AOBiome reports positive safety results in Phase Ib/IIa trial

23rd March 2018 (Last Updated March 23rd, 2018 00:00)

AOBiome Therapeutics has reported positive safety results from a Phase Ib/IIa clinical trial of its Ammonia Oxidizing Bacteria (AOB) product candidate for intranasal delivery to treat seasonal allergic rhinitis (SAR).

AOBiome reports positive safety results in Phase Ib/IIa trial
Illustration depicting inflammation associated with allergic rhinitis. Credit: BruceBlaus.

AOBiome Therapeutics has reported positive safety results from a Phase Ib/IIa clinical trial of its Ammonia Oxidizing Bacteria (AOB) product candidate for intranasal delivery to treat seasonal allergic rhinitis (SAR).

The trial aims to evaluate the safety and tolerability of the AOB candidate in up to 24 healthy subjects, and preliminary efficacy as a prophylaxis therapy in up to 42 individuals with a history of SAR due to ragweed pollen.

"We believe our intranasal approach has a number of potential applications beyond rhinitis, including migraines."

The results are included in the first part of the multi-dose, vehicle-controlled trial.

During this part of the study, AOBiome’s candidate demonstrated promising safety and tolerability when delivered intranasally to 24 healthy subjects over a period of two weeks.

The subjects were randomised in a 1:1:1 ratio to provide high dose AOB, low dose, and vehicle, during the study.

Results showed that all adverse effects were mild in severity, and none were considered to be related to the study drug.

No infectious or inflammatory complications or local/systemic adverse events related to study drug were reported. Additionally, the study did not find any change in nasal patency, anatomy, or architecture of subjects.

AOBiome president and CEO Todd Krueger said: “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.

“We believe our intranasal approach has a number of potential applications beyond rhinitis, including migraines.”

Based on results of the first part of the trial, AOBiome has started the second part of the Phase Ib/IIa trial to examine preliminary efficacy in patients with SAR.