US-based AOBiome has initiated a Phase II clinical trial of a therapeutic product candidate, B244, based on its proprietary ammonia oxidising bacteria (AOB) to treat mild to moderate acne vulgaris.
The trial is being carried out under an investigational new drug (IND) application to US Food and Drug Administration (FDA) and is the first to test the potential of live bacteria to treat skin disease.
AOB is a ubiquitous beneficial species of bacteria that converts ammonia from sweat into nitrite, which is antibacterial, and nitric oxide, a major signalling 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 capitalise on advances in understanding of the skin microbiome and the role of AOB’s play in restoring skin health.
“This initial clinical trial builds on preclinical studies demonstrating B244’s antibacterial activity and suggesting that B244 acts through multiple mechanisms, thereby reducing levels of bacteria linked to acne and reducing inflammation.
“The acne trial is the first of several indications we expect to pursue with B244 across a variety of skin disorders.
“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.”
Earlier studies demonstrated that AOB reside on the skin and in sweat glands and hair follicles, in close proximity to their energy source.
Approximately 36 patients will be enrolled in the placebo controlled, multiple ascending dose Phase II trial and they will be randomised to receive B244 or a placebo.
The trial’s primary endpoints are safety and tolerability, while its secondary endpoints include several measures of activity, including investigator global assessment, the number of inflammatory lesions and quality of life.
The company said its product candidate B244 incorporates a single strain of AOB, Nitrosomonas eutropha D23, selected for its anti-bacterial activity.