Positive Results on Clinical Development of BMB18
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Released
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ASX ANNOUNCEMENT
30 January 2025
Positive Results on Clinical Development of BMB18
● Biome has received positive results of core functional characterisation
●
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studies of its strain BMB18
The strain demonstrated an ability to effectively modulate immune
responses and inflammation, reduce oxidative stress, and maintain
intestinal barrier integrity.
This report will be used to help inform future clinical research
opportunities and potential health applications and targets for this strain.
Microbiome health company Biome Australia Limited (ASX: BIO) (‘Biome’ or ‘the
company’) is pleased to provide an update on the strain development program,
which was last updated on the 14th November 2024 following the successful
completion of the initial phase of the program, including initial validation of the
strain and transfer of the intellectual property to Biome.
Biome has now received the positive results of the core functional
characterisation studies conducted by the cell culture lab of one of Biome’s key
research partners. These in vitro studies investigated several functional
characteristics of Biome’s Lactobacillus plantarum BMB18 using two types of cell
cultures: Caco-2 cell assays (a model of the intestinal epithelial barrier) and
peripheral blood mononuclear cells (PBMCs) (used to study the stimulation of
immune responses).
The report’s findings showcase this probiotic strain’s functional potential, which
demonstrated an ability to effectively modulate immune responses and
inflammation, reduce oxidative stress, and maintain intestinal barrier integrity.
Clinical applications identified by the researchers
Importantly, this report will be used to help inform future clinical research
opportunities and potential health applications and targets for this strain.
The researchers indicated various aspects of health which may be positively
impacted by the identified functional characteristics.
It was suggested that the ability for BMB18 to reduce inflammation and enhance
immune responses in these studies may provide benefit in conditions with
immune dysregulation, such as chronic intestinal diseases or food intolerances.
It was also indicated that modulation of oxidative stress, which was
demonstrated by BMB18, is a critical factor in conditions such as cardiovascular
diseases, neurodegenerative disorders, and other chronic inflammatory diseases.
As this study also demonstrated that stimulation with BMB18 enhances epithelial
barrier integrity and reduces permeability, an ability to counter dysfunctions seen
in various intestinal disorders was also suggested by the researchers.
An overview of the study findings can be found on the following page in
Appendix 1.
Biome Australia’s Managing Director and Founder, Blair Vega Norfolk
commented:
“I am very pleased with this significant development and positive results in the
BMB18 program. This new data provides Biome with critical insights into the
functional characteristics and potential downstream applications for the novel
strain. As Biome continues the development of BMB18, as a key component of
Vision 27, there is a significant potential commercial pipeline for the strain for
new product development and also broadening the use of existing products.”
Appendix 1. Overview of study findings
Caco-2 cell culture studies
The Caco-2 epithelial cell model was used to study the ability of BMB18 to repair
and prevent intestinal tissue damage. Transepithelial electrical resistance (TEER)
and fluorescein isothiocyanate (FITC)-dextran 4 (FD-4) assays were used to assess
the influence of BMB18 on the integrity of tight junctions among intestinal
epithelial cells and cellular permeability respectively. Indirect assessment of
superoxide anion production was also performed by analysing reactive oxygen
species (ROS) production after cellular damage.
BMB18 was found to improve barrier function by restoring membrane integrity
and permeability in a statistically significant manner (p<0.05). BMB18 was also
found to be capable of reducing oxygen free radical levels, thus demonstrating
antioxidant activity (p<0.05) and an ability to modulate oxidative stress.
Peripheral blood mononuclear cell (PBMCs) culture study
Quantitative PCR (qPCR) was used to analyze the expression of various
inflammatory cytokines: interferon-γ (IFN-γ) and tumour necrosis factor-α (TNF-α)
(representing the main cytokines with pro-inflammatory actions), and
interleukin-10 (IL-10) and interleukin-4 (IL-4) (representing the main cytokines
with immune-regulating actions) in response to the presence of BMB18.
BMB18 was found to induce statistically significant (p<0.001) cytokine modulation
in PBMCs with and without an inflammatory stimulus. This probiotic strain can
therefore act as an immune activator or, if there is an inflammatory stimulus, it
can help to reduce the immune system’s inflammatory response. These
observations are in line with the understanding of certain strains of probiotics
being able to modulate the immune system in different ways depending on the
conditions.
-ENDSApproved for release by the Biome Australia board of directors.
About Biome Australia Limited
Biome Australia develops, licences, commercialises and markets innovative, evidencebased 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.
For more information visit: www.biomeaustralia.com
Investor Relations
Jo Power
+61 (3) 9017 5800
corporate@biomeaustralia.com
Media enquiries
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