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BiomeBank Announces World First Regulatory Approval for Donor Derived Microbiome Drug

  • Formal Therapeutic Goods Administration (“TGA”) approval of BiomeBank’s first-generation donor derived microbiome-based therapy.

  • BiomeBank to scale up its Good Manufacturing Practice (GMP) manufacturing facility to meet increasing global demand for its donor derived microbiome drug product -positioned for the treatment of recurrent C. difficile infection with a path to approval in additional conditions.

ADELAIDE, Australia--(BUSINESS WIRE)--BiomeBank today announced the first regulatory approval for a donor derived microbiome drug product worldwide.

The Therapeutic Goods Administration (TGA) approved BiomeBank’s product for restoration of gut microbiota in the treatment of recurrent Clostridioides difficile infection (C.difficile). C.difficile infection is the most common cause of health care associated diarrhoea, a debilitating condition with significant global unmet medical need.

BiomeBank's Co-founder and Managing Director Dr Sam Costello 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."

The microbiome-based product 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.

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.”

BiomeBank is a clinical stage biotechnology company, founded in South Australia in 2018.

About BiomeBank

BiomeBank is a clinical stage biotechnology company developing a pipeline of microbiome-based therapies to treat unmet medical need. BiomeBank's mission is to treat and prevent disease by restoring gut microbial ecology.

Backed by a world-leading team of translational microbiome experts, BiomeBank’s platform uses a unique combination of machine learning and microbiology to identify bacterial strains which influence disease, leading to the discovery and development of new therapies.


Amy Boyce
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Last Updated: 09-Nov-2022