With the potential launch of AOBiome’s live bacterial product as a first-in-class treatment for acne, ammonia-oxidising bacteria (AOB) could ultimately help combat the disease.

Currently in a Phase IIb clinical trial, AOBiome’s B244 seeks to penetrate the relatively stagnant, but well-established $3.0bn acne market.

Despite being the eighth most prevalent disease worldwide, and despite the need for more efficacious treatments, the acne market has been historically lagging behind in innovation. One of the major reasons for this has been that pharmaceutical companies have viewed topicals, the mainstay of acne therapy, as being inexpensive, with a poor return on investment. Instead, developers have relied on reformulations and label expansions of existing drugs as a low-risk, quick-reward strategy.

Fuelled by the continued unmet need for disease-modifying drugs, recent clinical activity, however, demonstrates a paradigm shift towards the development of molecules targeting critical pathways in acne pathophysiology. Among these, AOBiome’s B244 is a topical formulation incorporating a single strain of beneficial AOB, Nitrosomonas eutropha D23. The drug replenishes the skin’s balance of nitrite and nitric oxide, and regulates inflammation and vasodilation.

Given that Propionibacterium acnes has been thought to play a major causal role in acne pathogenesis, it may seem counter-intuitive that bacteria could treat the disease. However, according to a 2016 article in Scientific Reports, the skin microbiome is essential in protecting and maintaining skin health, similar to the gut microbiome. According to the report, species P. acnes and P. granulosum existed in higher proportions in healthy patients than in patients with acne, suggesting a potential probiotic role for these microbes.

Despite its promising mechanism of action, GlobalData believes that several challenges remain for B244 in its path to commercialisation. A major hurdle would be the lack of established regulatory pathways for live bacterial pharmacotherapy. Early and continued communication with the regulatory authorities will be paramount for AOBiome to ensure a successful launch of its potentially disruptive biotherapeutic in the acne market.