BiomeBank has announced the first regulatory approval for a donor-derived microbiome drug product worldwide.
The TGA has approved the company's product for the restoration of gut microbiota in the treatment of recurrent Clostridioides difficile infection (C.difficile).
C.difficile infection is the most common cause of healthcare-associated diarrhoea.
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 added, "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."