Available therapeutics

Regulated donor-derived treatments

BIOMICTRA® is widely used to treat C. difficile infections in clinical settings.

As Australia’s first regulated Class 2 donor-derived microbiome therapy listed on the ARTG, BiomeBank guarantees stringent multi-stage donor screening and expert nationwide support throughout the process.

What is BIOMICTRA®?

Our current product, BIOMICTRA®, is the world’s first microbiome-based therapy regulated as a biological.  BIOMICTRA® is donor-derived after stringent screening, and is available in a frozen syringe-based formulation for colonoscopy and enema delivery.  BiomeBank is reformulating BIOMICTRA® into capsule form with the encapsulated product expected be available through hospitals and pharmacies in the near future. BIOMICTRA® is manufactured in a purpose built Australian GMP facility, following rigorous quality-controlled screening and manufacturing processes. BIOMICTRA® currently supplied to hospitals and clinics throughout Australia and can be administered by healthcare professionals.

Media Release

BiomeBank announces world first regulatory approval for donor derived microbiome drug

The Evidence

Donor derived Faecal Microbiota Transplantation (FMT) is  a highly effective therapy for the treatment of recurrent Clostridioides difficile infection — the most common cause of healthcare associated diarrhoea. Multiple randomised controlled trials and meta-analyses of these studies have demonstrated the superiority of FMT over antibiotic therapy alone for the treatment of recurrent C.difficile infection.

While FMT is now the standard of care for recurrent C. difficile infection in most international guidelines, evidence is emerging for its use in other diseases. 

BiomeBank’s co-founders Associate Professor Sam Costello and Professor Rob Bryant have been pioneers in this field and BiomeBank is facilitating a number of clinical trials in a range of diseases with collaborating organisations.

Current Treatment (Antibiotics) vs Faecal Microbial Transplantation (FMT)

27%

Antibiotic Treatment

93%

FMT

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The development pipeline

BiomeBank has strong track record of commercialisation. Our donor-derived microbiome therapy was the first regulator-approved microbial therapy in the world. We are currently supplying this product to physicians in Australia to treat patients with C. difficile infection. BiomeBank is now leveraging the real-world, human data collected from these therapies as well as employing our cutting-edge CONSORTIOME® platform to engineer and test a pipeline of novel, co-cultured microbial therapies.

The potential drug candidates

• BB265

BB265 is a rationally designed cultured microbiome therapy engineered for the treatment of ulcerative colitis. BB265 was developed using BiomeBank’s CONSORTIOME® platform and data from a discovery trial using BIOMICTRA® (donor derived) therapy in patients with active ulcerative colitis. BB265 is now scheduled to enter a phase 1b/2a study.

• BB128

BB128 is a rationally designed cultured microbiome therapy engineered for the treatment of an orphan disease indication. A discovery trial in this orphan disease indication is underway using BIOMICTRA®