Aussie biotech secures world-first approval of microbiome therapeutic

Biotech News: The translation of research into the development of innovative and life-saving microbial therapies is set to transform in Australia as BiomeBank secures the first regulatory approval for a donor derived microbiome drug product worldwide.

The Therapeutic Goods Administration (TGA) has approved Adelaide-based BiomeBank’s Faecal Microbial Transplantation (FMT) product, Biomictra, for restoration of gut microbiota in the treatment of recurrent Clostridioides difficile infection. C.difficile infection is the most common cause of healthcare associated diarrhoea, a debilitating condition with significant global unmet clinical need.

Gastroenterologist Dr Sam Costello, Co-founder and Managing Director of BiomeBank, said “This approval is a landmark for BiomeBank and an important advance for microbiome therapeutics globally.

“We are thrilled to achieve market authorisation and intend to scale manufacturing of our donor derived microbiome drug product to meet the immediate medical need. In addition, we are excited to progress the development of our cultured microbiome based therapies with the aim of alleviating microbiome mediated disease on a much larger scale. It’s an exciting time for the microbiome field and we are pleased to be pioneering new solutions to treat these diseases.”

FMT has proved highly effective with efficacy of 85%–95% in C.difficile infection. The increased diversity and abundance of bacteria that the FMT provides to the GI tract outcompetes C. difficile and prevents reinfection.

BiomeBank’s Chief Technology Officer, Dr Sam Forster, said “We believe that microbiome-based therapies are set to transform the treatment of many diseases. BiomeBank is rapidly developing improved delivery methods and new second-generation microbiome-based therapies that are more standardised and targeted at specific diseases.”

Biomictra will first be launched as a frozen syringe formulation for colonic and enema delivery with oral delivery capsules for improved patient access to be made available in the near future.

FMT has also shown promise in the treatment of other diseases, including insulin resistance, liver disease and autism spectrum disorders and has been used successfully to induce remission in ulcerative colitis (UC). The company uses a combination of machine learning and microbiology to identify strains of bacteria that can cause disease, then creates new therapies as treatment.

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