Biomictra

History

2022: Australia first to officially allow microbiota transplant

On November 9, 2022, the Australian company BiomeBank announced that it had received approval from the local Therapeutic Goods Administration (TGA) for its gut microbiota-based drug Biomictra. This is the first time that any regulator in the world has officially authorized a similar type of therapy.

We are talking about fecal transplantation. The essence of the method boils down to the fact that a healthy donor supplies feces, on the basis of which capsules or microclysms are then created for patients. The goal is to populate the intestines of a person suffering from any disease with notoriously healthy bacteria.

Australia first to formally approve microbiota transplant

The drug Biomictra is designed to treat pseudomembranous colitis, a disease of the large intestine that is usually caused by the spore-forming anaerobic bacteria Clostridium difficile. The clinical manifestations of the disease are most often prolonged diarrhea, intoxication, abdominal pain and leukocytosis. The occurrence of pseudomembranous colitis is associated with frequent and improper use of antibiotics.

The microbiota-based BiomeBank product in the first stage will be produced as a frozen syringe composition, which, after thawing, will be able to be delivered to the rectum using an enema. The source material is supplied by specially selected healthy young people. In the future, it is planned to create a version of the drug for oral delivery, that is, ingestion.

This approval [from TGA] is an important milestone for BiomeBank and an important achievement in microbiota therapy worldwide. We intend to scale the production of our drug to meet urgent medical needs, "said BiomeBank Co-Founder and Managing Director Dr. Sam Costello[1][2]

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