By Thunicia Moodley, PhD, and Erin Mistry
Research in the area of live biotherapeutics has exploded in the last seven years. Even so, there is still much to learn about whether a dysregulated gut microbiome causes disease, or whether disease leads to dysbiosis. Dysbiosis has been implicated in multiple therapy areas including gastrointestinal disorders, immunology, neurology and oncology, among others. In addition, the therapeutic effects of several pharmaceuticals have been shown to be mediated by the gut microbiome.
Despite the scientific questions that remain to be investigated, several biotechnology companies have emerged with a focus on testing various approaches to developing therapies targeting the gut microbiome. Large, established pharmaceutical companies have also recognized the potential of live biotherapeutics and are investing in partnerships with these companies—or, as in the case of at least one company, are establishing an entire institute dedicated to the development of live biotherapeutics.
Although three therapies have reached Phase III development so far, they face numerous challenges in reaching the market—e.g., achieving regulatory approval, determining an appropriate price and obtaining reimbursement, and overcoming barriers to adoption of live biotherapeutics. Our paper provides a summary of the current gut microbiome therapy development landscape and an overview of the commercialization challenges faced.