BiomeBank, South Australian biotechnology company, has submitted its world-first biologic drug product to the Therapeutic Goods Administration for market authorisation.
The product treats recurrent Clostridioides difficile (C-diff) and Ulcerative Colitis and will be used to help meet medical needs across the Asia Pacific.
Already used in Australia to treat C-diff through faecal microbiota transplantation (FMT), BiomeBank’s product is also being positioned as an alternative to existing biologic therapies for Ulcerative Colitis.
It could be one of the first microbial therapies approved in the world, alongside companies like Ferring Pharmaceuticals and Series Therapeutics, according to BiomeBank CEO Thomas Mitchell.
“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,” Mitchell said.
“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 likeminded 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,” he said.
BiomeBank intends to bring the product to patients early in the treatment of their disease.
Amid its Series A funding round, the dossier submission was an important milestone for the company its investors, according to BiomeBank chair Dr Stephen Rodda.
“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,” Rodda said.
“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,” he said.
With a growing number of diseases linked to a loss of gut microbes, microbial therapies are increasingly recognised as effective treatments, according to BiomeBank chief medical officer and co-founder Dr Sam Costello.
“The approval of our GMP facility will enhance BiomeBank’s ability to provide these important therapies to patients in Australia and across Asia Pacific,” Costello said.
“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 LOTUS1 study has demonstrated promising results,” he said.