Biome Australia Expands BMB18 Trial to Top-Ranked Greek University

International Expansion Bolsters BMB18 Trial Credibility

Biome Australia Limited (ASX:BIO) has elevated its clinical trial ambitions by transforming the BMB18 probiotic study from a single-centre project at La Trobe University into a multi-centre international program. The addition of Harokopio University of Athens (HUA), ranked 2nd in Greece and top for research quality, not only broadens the recruitment base but also enhances the scientific credibility of the trial. This dual-site approach, under the guidance of Professor George Moschonis at HUA and the existing Melbourne team, reflects a strategic push to validate BMB18 across diverse populations.

Robust Protocol Targets Dose-Response Insights

The trial features a rigorous three-arm, double-blind, placebo-controlled design involving 240 participants. It compares two daily doses of BMB18; 1×10⁹ and 10×10⁹ colony forming units (CFU); against a placebo over six weeks, followed by a two-week observation period. Both sites adhere to a harmonised protocol, aiming to produce the first human clinical evidence for this proprietary strain. This setup is poised to clarify the optimal dosage and potential health benefits, building on pre-clinical data suggesting BMB18’s role in intestinal barrier function, immunomodulation, and antioxidant activity.

Trial Progress Aligns with Prior Announcements

Recruitment has commenced this week at both La Trobe and Athens, consistent with the Q4 FY26 timeline disclosed in Biome’s earlier patent filing announcement. All regulatory hurdles have been cleared, including ethics approvals and site agreements, and clinical trial products have been manufactured and delivered. This progress complements Biome’s broader momentum, which includes surpassing one million probiotic boxes sold and expanding international reach, as noted in its recent sales update Activated Probiotics surpasses 1 million boxes.

Proprietary IP and Patent Protection in Focus

BMB18 stands as Biome’s first wholly proprietary strain, with a patent application filed and undergoing examination. The company has deposited the strain under the Budapest Treaty, signalling an intent to secure global intellectual property rights. This aligns with Biome’s strategy to strengthen its competitive edge through proprietary innovations. Earlier filings highlighted the importance of this patent in underpinning future product development and commercialisation pathways Patent application lodged for proprietary probiotic BMB18.

Academic Partnerships and Market Implications

Collaborating with Harokopio University, renowned for its clinical nutrition research, positions Biome to leverage high-quality scientific expertise and potentially accelerate acceptance within the medical community. The international scope could also enhance the probiotic’s appeal in global markets, dovetailing with Biome’s ongoing expansion efforts. However, the final clinical outcomes remain uncertain, and the company prudently cautions that trial results and patent grants are not guaranteed.