(cenzi, Pixabay)
21 March 2018. First results from a clinical trial show a preventive treatment for seasonal allergies using live bacteria and given as a nasal spray is safe for patients. The study, sponsored by AOBiome Therapeutics in Cambridge, Massachusetts, is testing the company’s drug candidate code-named B244 formulated as a nasal spray.
AOBiome develops skin care products and therapies for several disorders that reintroduce ammonia oxidizing bacteria eliminated from the skin microbiome through modern hygienic practices. Ammonia-oxidizing bacteria, says the company, convert ammonia and urea from perspiration to nitrite and nitric oxide. Nitrite helps control the growth of other microbes, including pathogens, while nitric oxide is a signaling molecule that helps regulate inflammation.
In this case the bacteria, Nitrosomonas eutropha, are being tested for their ability to prevent seasonal allergies, known formally as seasonal allergic rhinitis, or more popularly as hay fever. People with this disorder have allergic reactions to trees, grasses, and weeds, such as pollen. The symptoms — familiar to seasonal allergy sufferers — are itchy and stuff nose, coughing, sneezing, runny nose, and watery eyes, among others. While treatments for these symptoms are available, there are few preventive measures other than avoiding exposure to allergens like pollen, which for many people is difficult.
The clinical trial is a two-part study, with the first part testing B244’s safety and tolerability as a nasal spray. The early-stage safety study recruited 24 healthy volunteers who sprayed B244 in each nostril once a day for 14 days, with a follow-up at 28 days to assess any reactions to the treatments. The results, reported by AOBiome, show no infections or complications affecting the nose in the participants, nor any changes in nasal functions or anatomy. In addition, no individuals discontinued their participation, with all adverse effects considered mild and unrelated to the nasal spray.
These findings allow the second part of the trial to proceed, an intermediate-stage study of the treatments’ ability to prevent allergic reactions. This part of the study is recruiting 42 individuals with allergies to pollen who are randomly assigned to receive B244 in a low or mid-range dose, or a nasal spray without the bacteria. After 14 days, participants will be rated on the presence of seasonal allergy symptoms, such as nasal congestion or sneezing, as well as an overall self-reported nasal symptom rating scale.
AOBiome first developed and tested B244 as a treatment for acne, but as reported in Science & Enterprise, found in clinical trials, B244 recipients experienced lower blood pressure. The company is now testing also B244 as a treatment for hypertension in an intermediate-stage trial.
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