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news.AOBiome has started a Phase II clinical trial of a therapeutic product candidate, B244, based on its proprietary ammonia oxidizing bacteria (AOB) to treat mild to moderate acne vulgaris.
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The Phase II trial is being conducted under an investigational new drug (IND) application to the US Food and Drug Administration (FDA) and is the first to test the potential of live bacteria to treat skin disease.
AOB is an ubiquitous beneficial species of bacteria that converts ammonia from sweat into nitrite, which is antibacterial, and nitric oxide, and a major signaling molecule with anti-inflammatory activities.
AOBiome CEO Spiros Jamas said: "B244 is classified as a ‘live-topical’, a brand new class of therapeutics to address skin diseases that capitalize on advances in understanding of the skin microbiome and the role of AOB’s play in restoring skin health.
"Current treatments, including cleansers and therapeutics often provide partial symptomatic relief but with risk of significant adverse effects. They also can exacerbate the condition by removing beneficial microbial species."
The randomized, placebo controlled, multiple ascending dose Phase II trial will include a total of 36 patents and they will be randomized to receive B244 or placebo.
The trial’s primary endpoints are safety and tolerability, while secondary endpoints include several measures of activity such as investigator global assessment, the number of inflammatory lesions and quality of life.
Earlier trials have showed that AOB reside on the skin and in sweat glands and hair follicles, in close proximity to their energy source.
The company claims that its product candidate B244 incorporates a single strain of AOB, Nitrosomonas eutropha D23, selected for its anti-bacterial activity.