The company behind Australia's first facility for the manufacturing of microbial therapies has applied to the Therapeutic Goods Administration for approval of their world-first biologic drug product.
South Australian based biotechnology company BiomeBank has submitted for market authorisation of their product for the treatment of recurrent Clostridioides difficile (C-diff) and Ulcerative Colitis.
The drug product is already used in Australia to treat C-diff through faecal microbiota transplantation (FMT) and has been positioned as an alternative to existing biologic therapies for Ulcerative Colitis.
BiomeBank CEO Thomas Mitchell said it is believed this could be one of the first microbial therapies approved in the world, alongside companies such as Ferring Pharmaceuticals and Seres Therapeutics.
"We're positioning BiomeBank as a global leader in microbial drug development with a GMP facility in South Australia, a first-generation microbial therapy now submitted for approval and a rapidly growing portfolio of second-generation products in the pipeline," said Mr Mitchell.
"Official Market Authorisation of our existing product will enable more patients in Australia to access this as a treatment option and allow our company to extend into the Asia Pacific market, highlighting Australia's capabilities in microbial drug discovery and development.
"While there are a number of like-minded companies across the globe working on discovering and developing similar products, we believe BiomeBank will be the first in the world to have an approved microbial therapy for these diseases."
Mr Mitchell also said the product's intended use has been positioned for recurrent Clostridioides difficile as well as mild to moderate Ulcerative Colitis, with the intention to bring the product to patients early in the treatment of their disease.
Amid its Series-A funding round, BiomeBank's chair Dr Stephen Rodda said the dossier submission was an important milestone for the company and its current and future investors.
"With microbial therapies set to transform the treatment of disease globally, BiomeBank is poised to become a leading biotechnology company and is truly positioning Australia as a global leader in drug discovery," said Dr Rodda.
"Harnessing an innovative and collaborative mindset, our leadership team is concurrently establishing critical partnerships with prominent research institutes across the country such as RMIT University and the Hudson Institute, translating world-class microbiome research into a variety of treatment options for patients across the world.
"Backed by a dedicated and passionate team, BiomeBank is already exceeding on its 2021 milestones and fast attracting both local and international interest from investors in our Series A funding round."
BiomeBank's chief medical officer and co-founder Dr Sam Costello explained that microbial therapies are being increasingly recognised as effective treatments across the globe.
"The approval of our GMP facility will enhance BiomeBank's ability to provide these important therapies to patients in Australia and across Asia Pacific," said Dr Costello.
"In addition to our existing syringe-based therapy, we are also developing capsule based-products that will allow improved patient access to our therapies.
"This is particularly relevant for the treatment of Ulcerative Colitis, where the LOTUS study has demonstrated promising results."
