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Australians were the first in the world to approve a drug based on intestinal microbiota

Polina Grebenkina, N+1

The Australian company BiomeBank has received approval from the Therapeutic Goods Administration (TGA) for its BIOMICTRA drug. The drug is designed to restore the intestinal microbiota in pseudomembranous colitis caused by Clostridioides difficile bacteria.

Pseudomembranous colitis is an inflammation of the colon mucosa, most often arising from a violation of the intestinal microbiome, due to which Clostridioides difficile begins to actively multiply. Toxins secreted by the bacterium cause an increase in the permeability of the intestinal epithelium, inflammation and tissue necrosis. One of the factors that increases the chances of the disease is considered to be excessive intake of antibiotics. Clostridioides difficile itself is resistant to antimicrobial drugs, which complicates the treatment of infections that it causes. According to research, fecal microbiota transplantation can successfully fight pseudomembranous colitis and even does it better than classical therapy.

Biotech companies are actively working on creating a method of microbiota transplantation, but so far such drugs have not been approved for use in any of the countries and have remained experimental. In 2018, the drug of the American company Seres Therapeutics reached the second stage, but clinical trials showed its ineffectiveness: eight weeks after treatment, the infection returned.

The Australian company BiomeBank has developed the drug BIOMICTRA and received approval for its sale. The drug is a suspension from the feces of healthy donors containing intestinal microbiota. In addition to microorganisms, there are food residues and intestinal epithelium of donors in the suspension — they remain in the sample as by-products when receiving the material.

The drug is available in a syringe, inside of which there is an active substance, as well as auxiliary components: saline and glycerin. All this is frozen for storage, and slowly thawed before use. The manufacturer recommends introducing BIOMICTRA during colonoscopy, but an enema or injection into the upper gastrointestinal tract is also allowed.

In July 2021, BiomeBank applied for a permit to sell the drug, and on November 9 of this year it received approval from the regulatory authority — the Australian Therapeutic Goods Administration.

Now BiomeBank will expand the production of the drug and continue to look for new ways of treatment with microbiome transplantation.

 So far, scientists are using donor stool samples, as this allows you to transfer as complete communities of microorganisms as possible. However, this technology is imperfect: even in BIOMICTRA, the composition varies from sample to sample. Perhaps soon scientists will learn how to collect the microbiome in a test tube, controlling its composition. The first step has already been taken, but there is not enough diversity of species yet.

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