CAMBRIDGE, Mass.--(BUSINESS WIRE)--AOBiome today announced it has begun a Phase 2 clinical trial with a therapeutic product candidate based on its proprietary ammonia oxidizing bacteria (AOB) for the treatment of mild to moderate acne vulgaris. The trial with the product candidate, B244, is being conducted under an IND application to the FDA and is the first to test the potential of live bacteria to treat skin disease.
”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,” said Spiros Jamas, ScD, AOBiome’s CEO. “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.
“There is an important need for new acne treatments,” Dr. Jamas, noted. ”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.”
AOB are a ubiquitous beneficial species of bacteria that convert ammonia from sweat into nitrite, which is antibacterial, and nitric oxide, and important signaling molecule with anti-inflammatory activities. Studies have shown that AOB reside on the skin and in sweat glands and hair follicles, in close proximity to their energy source. AOB also produce a beneficial reduction in pH by reducing ammonia levels. AOB are however eliminated by most soaps. AOBiome’s therapeutic strategy is based on restoring AOB to the skin microbiome.
B244 incorporates a single strain of AOB, Nitrosomonas eutropha D23, selected for its anti-bacterial activity. In preclinical studies, B244 produced reductions in levels of pathogenic bacteria, including Propionibacterium acnes, the species linked to acne and improved healing of damaged skin. In addition to preclinical safety studies, Nitrosomonas eutropha D23 was safe and well tolerated in a human cosmetic safety study.
The Phase 2 clinical study is a randomized, placebo controlled, multiple ascending dose trial involving 36 patents randomized to receive B244 or placebo. The primary endpoints are safety and tolerability. The study’s secondary endpoints include several measures of activity, including investigator global assessment, the number of inflammatory lesions and quality of life.
AOBiome is developing a transformative, new class of products based on Ammonia Oxidizing Bacteria (AOB) to improve skin health and prevent or treat skin diseases. The company’s topical products are designed to provide benefits by restoring the natural, protective balance afforded by beneficial skin microbes that have been lost due to modern living practices, including antibiotic use, soaps, and shampoos. AOB are ubiquitous bacteria that oxidize ammonia and urea in sweat, to nitrite, an anti-microbial compound, and nitric oxide, a well documented signaling molecule in the inflammatory process. AOBiome is developing a pipeline of topical biologics to treat acne, eczema, rosacea and other inflammatory skin diseases. Learn more at www.aobiome.com.