19 October 2017. First results of a clinical trial show a spray-on formulation of live bacteria reduced the amount and severity of acne in people with mild to moderate cases of the condition. The findings are reported today by AOBiome Therapeutics in Cambridge, Massachusetts, creator of the treatment code-named B244.
AOBiome develops therapies for acne and other disorders by reintroducing bacteria that oxidize ammonia 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.
Acne, known formally as acne vulgaris, is a chronic inflammatory condition that blocks hair follicles and sweat glands, primarily on the face, chest and back, affecting some 40 to 50 million people in the U.S., according to data cited by the company. AOBiome says eliminating commensal or natural bacteria from the skin also removes the nitric oxide leaving the skin as a pro-inflammatory environment.
The intermediate-stage clinical trial tested B244, formulated as a topical spray that applies Nitrosomonas eutropha, an ammonia-oxidizing bacteria, on affected areas of the skin. The study enrolled 358 individuals with mild to moderate acne, randomized to spray B244 or a placebo to the entire face, twice a day for 12 weeks. Participants took part in the study remotely and applied the treatments themselves, with data reported through a smartphone-based telemedicine system known as Network Oriented Research Assistant, provided by contract research organization, Science 37.
The results show participants spraying B244 report fewer inflammatory lesions associated with acne than individuals using the placebo, as well as less severe acne as determined by an investigator’s global assessment scale used to measure severity of skin disorders, including acne. The company says B244 sprays are well tolerated by participants, with no adverse effects reported from the treatments.
AOBiome says, based on the results, it plans to expand its product line to treat other inflammatory skin disorders, such as atopic dermatitis, pruritus, and rosacea. In addition, the company is testing a treatment for allergic rhinitis, or hay fever, in an early-stage trial.
The company is also testing B244 as a treatment for hypertension. As reported by Science & Enterprise, AOBiome found in an earlier trial a high correlation between the dose of B244 received in the facial spray and blood pressure of participants. The effect, says the company, was strong enough to reach statistically reliable levels at the highest dose. AOBiome adds that since it discovered this effect, the company engaged experts on blood pressure to verify a possible mechanism linking ammonia oxidizing bacteria on the vascular system.
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