Ethics Approval Granted for BMB18 Human Clinical Trial
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
3 February 2026
Ethics Approval Granted for BMB18 Human Clinical Trial
● Randomised, double-blind, placebo-controlled trial recruiting 240
participants to investigate the efficacy of proprietary strain Lactobacillus
plantarum BMB18 (DSM 35214) in adults experiencing digestive
symptoms, sleep and mood disturbances
● La Trobe University Human Research Ethics Committee grants ethics
approval, clearing the final regulatory prerequisite for the trial to
commence in February 2026 as planned
● Two active dosage levels and placebo to identify multiple use cases in
new product development with Biome-owned IP
● BMB18 is wholly owned by Biome, representing valuable and
protectable intellectual property that strengthens the Company's
competitive position and underlying asset value
● Successful clinical outcomes will unlock new product development
opportunities across the Activated Probiotics and Activated
Therapeutics ranges
Microbiome health company Biome Australia Limited (ASX: BIO) (‘Biome’ or
‘the Company’) is pleased to advise that the La Trobe University Human
Research Ethics Committee (HREC) has granted ethics approval for the
Company’s first human clinical trial on its proprietary probiotic strain,
Lactobacillus plantarum BMB18 (DSM 35214)
The approval clears the final regulatory prerequisite for the trial to commence
in February 2026, consistent with the timeline outlined in the Company’s
announcement on 15 December 2025.
Trial Overview
The randomised, double-blind, placebo-controlled trial will recruit 240
participants across two active dosage levels and placebo to investigate the
efficacy of BMB18 in adults experiencing digestive symptoms (e.g. bloating,
discomfort) and/or occasional sleep or mood disturbances, and examine its
impact on digestive function, mood, sleep and quality of life.
Two active dosage levels will be investigated alongside placebo to identify
multiple use cases in new product development with Biome-owned IP. The
12-month study will be conducted for approximately $140k and managed
within Biome’s existing R&D budget.
The trial follows the successful completion of in vitro research demonstrating
BMB18’s ability to modulate immune responses and inflammation, reduce
oxidative stress, and maintain intestinal barrier integrity (Ref announcement
30 January 2025).
Intellectual Property and Product Development
BMB18 is wholly owned by Biome and registered with the German culture
bank DSMZ (DSM 35214), providing the Company with protectable intellectual
property and future licensing opportunities.
Successful clinical validation of BMB18 will support new product development
across both the Activated Probiotics and Activated Therapeutics ranges, with
the potential to address multiple health applications identified during the in
vitro phase. Biome’s ownership of the strain and its clinical data provides a
meaningful competitive advantage and adds to the underlying value of the
business.
Gut disorders and targeted gut health remain Biome’s largest volume
category. Clinical validation of BMB18 is expected to support growth across
existing products while enabling new product innovation.
Strategic Alignment
The BMB18 clinical trial aligns with Biome’s Vision 27 strategic plan, specifically
the supply chain development pillar focused on identification, characterisation
and commercialisation of proprietary probiotic strains. The trial continues
Biome’s successful research partnership with La Trobe University, following the
Biome Lift™ Probiotic clinical trial collaboration.
Biome Managing Director and Founder Blair Vega Norfolk said:
“Receiving ethics approval from La Trobe University is the final step before
commencing this important trial. We are on track to begin recruiting
participants this month.
BMB18 represents one of the most significant assets we have built at Biome. It
is a proprietary strain that we own outright, registered internationally, and
supported by strong in vitro data. Clinical validation will enable us to develop
new products with IP protection that strengthens our competitive position in
a growing market.
The value of owning a clinically validated, proprietary probiotic strain cannot
be overstated. It provides Biome with product development opportunities,
protection from competition, and potential licensing pathways that
contribute to the long-term value of the Company.”
–ENDS–
Approved for release by the Biome Australia board of directors.
Investor Hub
Biome has launched a new interactive investor hub. To view a video presentation of
this announcement, ask questions or sign up for future company updates, please visit
the investor hub via this link (https://investorhub.biomeaustralia.com/).
About Biome Australia Limited
Biome Australia develops, licenses, commercialises and markets innovative,
evidence-based live biotherapeutics (probiotics) and complementary medicines, many
of which are supported by clinical research. Biome aims to improve health outcomes
and quality of life, and make its products accessible to all.
Incorporated in Australia in 2018, Biome distributes locally and abroad. In partnership
with some of the world's leading organisations in microbiome research and
development, Biome produced several unique live biotherapeutic (probiotic) products
with innovative delivery technologies that improve their stability and efficacy to create
its flagship range of complementary medicines: Activated Probiotics
®
.
Supported by clinical research, including randomised double-blind placebo-controlled
trials, Activated Probiotics help prevent and support the management of various
health concerns, including low mood and sleep, bone health, iron malabsorption, mild
eczema and IBS. Through practitioner-only distribution, Biome is committed to
educating health professionals on the newfound systemic health effects of the gut
microbiota, helping them to provide innovative, evidence-based natural medicines for
the management of some of humanity's most prevalent and chronic health concerns.
Biome also develops, licenses and distributes a scientifically formulated, organic
nutraceutical range, Activated Nutrients
®
.
For more information visit: www.biomeaustralia.com
Investor Relations
corporate@biomeaustralia.com
(03) 9017 5800
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