Gut Instinct: ASX health stocks tap into rising awareness of microbiome
The microbiome is a key area of biomedical research, with links to conditions from cancer and obesity to mental health
Microba has become a leader in microbiome testing, first focused on diagnosing unresolved lower gastrointestinal disorders
Genomic research and product development company EZZ targeting Helicobacter pylori, a bacterium that grows in the digestive tract
Dubbed 'the forgotten organ', the gut microbiome is now firmly in the spotlight, as science catches up to its essential role in human health. And it's become a key focus for biomedical research companies.
Microba Life Sciences (ASX:MAP) CEO Dr Luke Reid told Stockhead the gut microbiome consists of trillions of bacteria, viruses, fungi, and other microorganisms living in our digestive tract.
Reid said chronic diseases – including conditions such as gastrointestinal, mental health, cardiovascular, cancer, autoimmune and allergies – collectively represent more than 90% of the ~US$4.5 trillion annual healthcare spend in the United States.
"The gut microbiome is implicated in essentially all these conditions," he said.
"There are more than 21,000 research publications demonstrating a clear link between chronic diseases and the gut microbiome.
"More than 150 global clinical studies demonstrate that microbiome modulation can improve disease outcomes and clinical symptoms."
Reid said the future of the rapidly growing gut microbiome sector was taking shape in two key areas – diagnostic and therapeutics.
The US Food and Drug Administration (FDA) has approved two microbiome-based treatments, with both designed to treat Clostridioides difficile infections, which causes inflammation of the colon, known as colitis.
Reid said that Microba's core vision was that testing and monitoring of the gut microbiome could become a routine part of medical care with your doctor, Reid said.
Following on from that, the company wants to see microbiome-based therapeutics approved and routinely used for treatment of multiple chronic diseases.
"If taken together – and microbiome diagnostics and therapeutics indeed play a meaningful role in supporting patients – it could be a US$1.4 trillion healthcare disruption opportunity," Reid said.
"Breaking that down, we believe the diagnostics side is worth more than US$100 billion and the therapeutic side around US$1.3 trillion."
Leader in gut microbiome testing
Microba was co-founded by internationally renowned researchers Professor Philip Hugenholtz and Professor Gene Tyson in 2017.
It was based on their world-leading proprietary technology out of the University of Queensland to analyse the gut microbiome.
Hugenholtz now chairs the company's scientific advisory board, while Tyson serves as a non-executive director.
Former Australian of the Year Professor Ian Frazer, co-inventor of the cancer-preventing HPV vaccines Gardasil and Cervarix, serves as deputy chairman of Microba's board and chairs its medical advisory board.
The company has grown to become a global leader in microbiome testing and is first focused on diagnosing unresolved lower gastrointestinal disorders.
"This first target patient group represents a US$25bn opportunity, out of the more than $100bn opportunity for this new diagnostic category of clinical microbiome testing," Reid said.
Partnership deal with Sonic healthcare
Microba inked a partnership deal in 2022 with medical diagnostics giant Sonic Healthcare (ASX:SHL), which acquired around ~20% in the company with a $17.8 million investment.
Under the deal, Sonic is supporting the roll out of Microba's MetaPanel microbiome tests into its major markets. That will start in Australia, with a clear view to expand to the UK, US, Germany, Switzerland, New Zealand and Belgium.
Sonic made a further investment in 2023 to support Microba to accelerate entry into the UK.
Reid said the company estimates there are 82 million patients with lower gastrointestinal symptoms seeing a doctor annually across its core focus markets of the US, UK, Australia, Germany, France, Spain and Italy.
"The data suggests that half of these patients are not getting a resolution,' he said.
"One of the first questions a clinician will ask is whether there is a potential pathogen infecting the patient?
"The current tool available tests for around 20, and with our technology we can test for every clinically relevant gastrointestinal pathogen.
"If we identify a bad pathogen, we can give guidance to the clinician on what type of antibiotic to use."
Early results
Preliminary results from analysis of MetaPanel tests show it can detect a pathogen in 24% of patients, providing a critical new treatment path for a significant portion of these patients.
Reid said if no pathogen was identified, doctors would want to rule out colorectal cancer and inflammatory bowel disease through a colonoscopy.
"If nothing is found those group of patients end up what is classed as a functional intestinal disease or irritable bowel diagnosis (IBS) diagnosis, and either receive no further support, or receive non-specific dietary advice and sometimes mental health support," he said.
Reid said their second test MetaXplore was specifically designed for those patients, assessing the integrity of the gastrointestinal tract, together with the the structure and function of the microbiome.
Preliminary results from analysis of more than 4600 MetaXplore test results, demonstrate it can support clinicians to identify and address underlying gut issues that often go undetected by conventional testing.
In more than 70% of cases, the test revealed findings, such as abnormalities in gut bacteria, signs of infection, markers of inflammation or insufficiency that could inform targeted treatment strategies.
Further, two-thirds of MetaXplore patients in a separate study of follow up survey results reported improvement of symptoms after their care was guided by the test results.
"That is significant outcome for a group of patients who have previously been unable to find answers to their symptoms,' Reid said.
"We have seen patients that have been suffering for 10, 20, even 30 years, now completely resolved."
EZZ targeting gut bacteria Helicobacter pylori
Also targeting the gut microbiome is genomic research and product development company EZZ Life Science (ASX:EZZ).
EZZ is targeting four key health areas including longevity, human papillomavirus (HPV) weight management and Helicobacter pylori (H. pylori).
A bacterium that grows in the digestive tract, H. pylori can cause stomach ulcers, increase the risk of stomach cancer and lead to a rare type of stomach lymphoma.
Due to its link to stomach cancer, H. pylori was designated a human carcinogen by the World Health Organization's International Agency for Research on Cancer in 1994.
More recently, in 2021, the US National Toxicology Program included chronic H. pylori infection in its 15th Report on Carcinogens, listing it among agents known or reasonably anticipated to cause cancer in humans.
"We identified gut health as a key platform for health and wellbeing," chairman Glenn Cross told Stockhead.
"If you look at the data, plant-based and fermented foods are very important from a dietary perspective, along with exercise, sleep and drinking lots of water.
"But a lot of health professionals say probiotics and prebiotics are also important and that is where we came from with our first product the Helicobacter pylori probiotic."
Cross said the company was also planning on launching two gut health products under its EZZDay label in the US, when it launches into the world's largest healthcare market later this year.
"They will be a combination of probiotics, enzymes and adaptogens," he said.
The former AusBiotech CEO said the gut microbiome was becoming an increasing area of interest for healthcare companies.
"Over the last decade and certainly at my time at AusBiotech we saw a lot more companies becoming involved in products for the gut microbiome," Cross said.
Biome Australia capitalising on 'explosion of interest in the microbiome'
Biome Australia (ASX:BIO) is also targeting the microbiome for its flagship complementary medicine line Activated Probiotics.
Director of Education Rebecca Edwards told Stockhead its clinically validated product lines feature both complete formulations and specific probiotic strains, with each supported by human clinical trials demonstrating targeted health benefits.
"In the world of probiotics specificity is everything," she said.
"Each strain of probiotic bacteria has its own genetic profile and performs its own specific mechanisms."
She said two strains of bacteria may seem similar looking at their names but may be used in different health conditions.
For example, the company uses Lactobacillus salivarius LS01 in its Biome Eczema product, while Biome Acne contains Lactobacillus salivarius LS03.
"This is where research is so important, with several of our products being condition-specific, targeting a defined health concern," she said.
"The specific formulation of these products has been clinically trialled in human studies, meaning we can have a good understanding of how this precise combination of strains can make a difference in a particular health condition."
Edwards said part of Biome's mission was to help prevent disease.
"It's exciting to be having discussions with health care practitioners about how they can use probiotics as part of their approach to keep their patients well," she said.
"There's an explosion of interest in the microbiome.
"While our own microbial communities may be invisible to the naked eye, their impact is being increasingly understood, and respected."
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