Biome Australia Kicks Off International Trial for Its First Wholly Owned Probiotic Strain
BMB18 multi-centre clinical trial kicks off across Australia and Greece
Recruitment has commenced this week for the Biome Australia (ASX: BIO) BMB18 clinical trial across two international academic sites: La Trobe University in Melbourne and Harokopio University of Athens (HUA). The addition of the Athens site represents new information disclosed to the market for the first time, expanding what was previously a single-centre study into a concurrent international programme. All logistics are confirmed in place, with the commencement timeline consistent with the company’s prior disclosure on 27 April 2026.
Key highlights from the trial launch include:
- 240 participants enrolled across two sites
- Three-arm, double-blind, placebo-controlled design
- Two dosage levels tested: 1×10⁹ CFU/day and 10×10⁹ CFU/day versus placebo
- Six-week intervention period followed by a two-week post-intervention follow-up
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A stronger trial by design — why two sites matter
From single-centre to international programme
The BMB18 trial was originally structured as a single-centre study at La Trobe University. It has since been expanded to incorporate HUA as a concurrent second site, operating under a harmonised protocol with site agreements executed in materially equivalent terms. This multi-centre configuration was not previously disclosed to the market, making it a material update to the announcement released on 27 April 2026.
The Athens partnership
The Athens site is led by Professor George Moschonis, Professor of Human Nutrition at HUA. The university is ranked 2nd in Greece overall and 1st in Greece for Research Quality in the Times Higher Education World University Rankings 2026. HUA’s School of Health Science and Education, which houses the Department of Nutrition and Dietetics, is widely recognised across Europe for its clinical nutrition and dietetics research output.
Blair Vega Norfolk, Founder and Managing Director
“Expanding the BMB18 program to a multi-centre international design, with two internationally respected academic centres running concurrently under Professor Moschonis in Athens and the existing team at La Trobe in Melbourne, materially strengthens the credibility and recruitment footprint of the trial. Commencing recruitment this week at both sites, within the timeline previously disclosed, is an important step in the maturation of Biome’s proprietary IP platform.”
Understanding BMB18 — Biome’s first wholly proprietary strain
BMB18, with the full scientific name Lactiplantibacillus plantarum, DSM 35214, is the first wholly proprietary strain in Biome’s intellectual property pipeline. Unlike strains that are licensed from third parties, Biome owns this IP outright, meaning the company retains full control over its commercial and clinical applications.
Pre-clinical work has characterised a triple mechanism of action for BMB18 across three areas:
- Intestinal barrier function
- Immunomodulation
- Antioxidant activity
A patent application covering the strain and its applications has been filed and is currently pending examination. The corresponding Budapest Treaty patent deposit at DSMZ is also in progress. It is important to note that patent grant is not guaranteed, as applications remain subject to examination processes.
This trial is designed to generate the first human clinical evidence for the BMB18 strain specifically, tested concurrently across two independent academic populations. Clinical trial results cannot be predicted and may not support commercial development.
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Trial infrastructure complete — what’s next for investors
Readiness milestones already met
All key operational requirements for the trial were confirmed in place ahead of recruitment commencing. The table below summarises the current readiness status across each milestone.
| Milestone | Status | Detail |
|---|---|---|
| Site agreements executed | Complete | Both sites, materially equivalent terms |
| Ethics approvals | In place | Both La Trobe University and HUA |
| Clinical trial product | Manufactured, released, and delivered | Both sites confirmed |
| Recruitment | Commenced this week | Q4 FY26 timeline met |
| Protocol harmonisation | Confirmed | Three-arm, double-blind, placebo-controlled |
What to watch from here
Biome has confirmed it will provide further updates on the programme in accordance with its continuous disclosure obligations. No interim or final trial readout date has been disclosed, and investors should not assume a specific timeline for results.
Key areas of focus for investors from this point include the progression of recruitment across all 240 participants at both sites, the timing of any trial readout once data collection is complete, and the ongoing examination of the filed patent application. The Budapest Treaty patent deposit at DSMZ is also in progress, representing a further step in formalising the intellectual property position around BMB18. As with all clinical programmes, outcomes cannot be predicted in advance.
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