The gut microbiome has clear implications for health and disease. Recent evidence of this comes from a US FDA vote for approval of the microbiome-based drug RBX2660, created by Rebiotix Inc, A Ferring Company, to treat potentially deadly bacterial infections with Clostridium difficile (Cdiff). Cdiff is a common gut bacteria that may cause severe diarrhea and illness in vulnerable people. It often spreads in hospitals and can be resistant to treatment. While this was still echoing in the field of microbiome biotherapeutics, recent news published in the Guardian showed that an Australian company, BiomeBank, became the first company in the world to receive regulatory approval for its live biotherapeutic product. The Australian government recently approved BiomeBank’s donor-based fecal transplant strategy, making it the first fecal microbiome transplant (FMT) with regulatory approval in the world. While FMT has been available as a treatment for several years, it has lacked formal regulations, making the process uncertain and risky. Now, with formal regulatory approval, safety and consistency standards are in place to assure the performance of the product. For such a transplant, stool donors must fulfill a certain list of criteria to avoid unwanted bacterial contamination and immune response in recipients. Those who fulfill the criteria then can provide their stool samples to propagate the genetic content of their fecal microbiomes in unhealthy recipients. The microbes are filtered from the healthy stool and delivered into the gastrointestinal tract of unhealthy patients to treat deadly infections such as Cdiff. BiomeBank has a robust donor program in place to collect stool samples from healthy donors for transplant into the colon of unhealthy individuals. For now, the transplants are only delivered via the colon, but oral delivery is expected to be available soon.
The managing director of BiomeBank, Sam Costello, said the fecal microbiota transplant product had been provisionally available to patients for several years. However, the grant of regulatory approval by the Therapeutic Goods Administration (TGA) to BiomeBank would ensure an essentially pharmaceutical standard for fecal microbiome transplants. According to Mr. Castello, BiomeBank is the first to meet a pharmaceutical standard, and that would give confidence to physicians to prescribe fecal transplant therapy to their patients who need it. The TGA approval is only for treating recurrent Cdiff infection, but Costello says this opens a path to the future approval of microbiome therapies for other conditions. Many studies have identified links between the microbiome and mental health, cancer, immunity, obesity and other conditions. Moreover, it is a known fact that human microbiomes, particularly in the West, have been becoming more and more depleted due to both environmental and dietary changes. Consequently, BiomeBank is now screening more donors to tackle Cdiff, but also eventually other disorders. Although the pandemic crippled BiomeBank’s donor pool, it also led to less travelling and exposure to exotic gut parasites, as well as fewer colds and antibiotic prescriptions, all of which eliminate otherwise healthy donors. This may lead to opportunities for others to donate who may have been eliminated pre-COVID, leading to an increasingly diverse product that could be applicable to a wider array of gut-related diseases. To read more, please visit the Guardian website.