A biotechnology company announces the world’s first regulatory approval for a donor derived microbiome drug product

Researchers at BiomeBank have just announced the approval of a new drug product that can be used to treat a chronic infection called clostridioides difficile infection, also known as C. difficile infection. This infection causes severe diarrhea in patients, and is now more prevalent due to frequent use of antibiotics.

The treatment product

The microbiome-based product will first be launched as a frozen syringe formulation for colonic and enema delivery. Then, it will eventually include oral delivery capsules for improved patient access in the future.

 The company hopes to increase its Good Manufacturing Practice (GMP) — a system that would ensure the product is produced consistently and made at quality standards — so that it can produce more of the needed product, which is in high demand for its novel drug treatment, according to the biotech company.

“We are thrilled to achieve market authorization and intend to scale manufacturing of our donor derived microbiome drug product to meet the immediate medical need,” stated Dr. Sam Costello, co-founder and managing director of BiomeBank. It is the first company globally to have regulatory approval for a donor derived microbiome drug product.

The company BiomeBank and its treatment

BiomeBank is a clinical stage biotechnology company located in Australia that develops microbiome-based treatments to provide support for various medical needs. It was founded in 2018. 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. Although TGA has currently only approved BiomeBank’s product for the treatment of C. difficile infection, the biotech company hopes that the approval of the product is just the beginning for creating many treatments for other illnesses. “We believe that microbiome-based therapies are set to transform the treatment of many diseases,” said Dr. Sam Forster, the chief technology officer at BiomeBank.

The company previously approved its first-generation donor derived microbiome-based therapy product, known as BIOMICTRA. The product is registered in the Australian Register of Therapeutic Goods (ARTG), a public database of therapeutic goods that can be legally provided throughout Australia.

Microbiome-based therapy

According to BiomeBank’s company website, therapies that are based on the microbiome, also called microbiome therapeutics, have proven to help restore patients’ gut microbial ecology, or gut bacteria, leading to treatment of different infectious diseases.

This is typically done using Faecal Microbial Transplantation (FMT), the process of transplanting the microbial found in the gut of a healthy donor into a patient with prolonged disease. The FMT treatment has been shown in clinical trials to effectively treat clostridioides difficile infection, preventing recurring infection in 81%-96% of patients who showed marginal side effects. The treatment also worked better than taking antibiotics alone. The approval of the novel product is unprecedented and is the first time that a donor derived microbiome drug product has ever been approved.

“This approval is a landmark for BiomeBank and an important advance for microbiome therapeutics globally,” said Dr. Costello. “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,” he continued. “It’s an exciting time for the microbiome field and we are pleased to be pioneering new solutions to treat these diseases.”