The eventual goal is to develop clinically validated and affordable probiotics that are recognised as adjunct therapies by the regulator and are qualified for government subsidies.
“There are many probiotics products in the world market. The ones that go through the rigours of science and are proven in its final, finished formulation will benefit the patient category,” CEO Dr Sean Hall told NutraIngredients-Asia.
“We see probiotics as a very meaningful, important medicine and as a very important adjunct therapy to standard care.”
“And so, we have to prove and to ultimately bring probiotics as registered pharmaceuticals that at the end of the day, can be subjected to the same type of government or healthcare co-pay that any other drug is subjected to.”
The ASX-listed company recently disclosed the preliminary findings of a phase IIa clinical trial conducted on its probiotic product NRGBiotic.
Containing Lactobacillus acidophilus, Bifidobacterium bifidum, streptococcus thermophilus, coenzyme Q10, and magnesium orotate, the product claims to balance mood and enhance energy.
The preliminary finding said using the probiotic as an adjunctive to anti-depressant medications have led to significant reduction in depression scores and improvement in quality of life from baseline.
It has also proved to be safe and tolerable with no reported adverse effects in the blinded, placebo-controlled trial involving 120 patients.
The full results are expected to be published about half a year later.
This is the fourth human clinical study conducted on the probiotic formulation.
At the moment, the product is used by doctors as the “last line of treatment”, together with anti-depressant drugs to treat major depression when patients are not responding well to anti-depressants alone.
“Over the next couple of years, as the data becomes more robust, we will seek to change that, but at this point, it is the last line of treatment,” Dr Hall said.
“We hope that the endgame for NRGbiotic will be as an adjunct [middle line or frontline] therapy to an anti-depression,” he said.
“We have to wait for the final report [of the trial findings] then sit down with the Therapeutic Goods Administration (TGA) and develop what we will hope to be the last stage trial allowing us to move it into a drug application.”
At the moment, most of the practitioners prescribing the probiotic are in the mental health advocacy space.
“Whether it is a GP or specialist, psychiatrists or psychologists, we are seeing more and more clinics that specialise in supporting patients with mental health issues take on the product, or pharmacies around them onboard the products to support the patients from the local clinics.”
The company is also studying the use of probiotics as adjunctive oncology treatment, as well as for managing NCDs.
Dr Hall said the firm has been studying its MultiBiotic product in relieving mucositis – which occurs when a cancer treatment breaks down the epithelial cells lining in the gut of chemotherapy patients. This leaves the mucosal tissue open to ulceration and infection.
MultiBiotic contains seven probiotic strains, namely Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus plantarum, Bifidobacterium animalis ssp. Lactis, Bifidobacterium breve, Bifidobacterium bifidum, and streptococcus thermophilus.
According to the labelling, the product claims to improve gut health, support immune function, and reduce medically diagnosed irritable bowel syndrome.
The firm also finished three phase I studies on three different probiotics for obesity and diabetes and have achieved “good outcomes”.
“We know from medical literature that the chronic diseases we see today are all levied from the gut and proper restitution of the gut may alleviate a lot of symptoms and subsequently the problems the patients are experiencing.”