The dual targeted formulation, named as Gastrointestinal ReProgramming (GaRP), works in the small intestine and colon.
The ASX-listed company is also assessing a subset of the formulation, named as 3FDC – which specifically targets the colon, in influencing the psychological functioning in adults suffering from moderate level of depression, anxiety, or stress symptoms.
Unlike most of the gut health supplements presently available in the market, both GaRP and 3FDC do not contain probiotics.
The company declined to reveal details on the formulations that are pending patent but said that GaRP contains bromelain – an enzyme extracted from the pineapple stem, while 3FDC contains ingredients that modulate the gut-brain axis.
“It is known that the IBS patients also have mental health challenges, for example, anxiety and stress.
“We thought that given the mechanisms of action that 3FDC has, we should also explore it in the broader population, not only IBS patients, but also adults without IBS but are experiencing anxiety and stress,” CEO Steve Lydeamore told NutraIngredients-Asia.
The 3FDC formulation was devised when the company was evaluating the individual ingredients used in GaRP and assessing the impact of different ingredient permutations.
The company is traditionally in the animal health business, where it has developed a bromelain-based supplement that produces anti-inflammatory effects and could reduce the incidence of diarrhoea.
Based on this concept, the company then went on to develop a bromelain-containing complementary medicine which also contains other ingredients for IBS and inflammatory bowel disease (IBD) patients.
At present, both GaRP and 3FDC are not yet commercialised. Lydeamore said the company’s intention was to develop and sell the GaRP finished complementary medicine in the domestic market, while taking a technology supplier approach in the overseas market.
“We want to wait for the human clinical data first before introducing the products into the market,” he said.
IBS diarrhoea trial
The company is starting on its first human clinical study – a two-stage RCT – on GaRP, with the aim of evaluating the safety and efficacy of GaRP in IBS patients suffering from frequent diarrhoea.
The trial aims to recruit 200 patients, with recruitment starting from next month.
In the first stage, 90 patients will be randomised into three groups, namely the placebo and the other two will be supplemented with GaRP of two different dosage strengths.
Following interim analysis, one dose will be selected and studied in the second stage of the trial involving 110 patients.
Both stages will last for 12 weeks each, consisting of a two-week baseline screening, eight-week intervention, and two-week washout period.
The GaRP supplement will be given in the form of sachets containing mini granules.
Parameters, including the IBS-severity scoring system, IBS-quality of life, and Bristol Stool Form scale, will be measured.
This study will build up existing evidence which the company has gathered from in-vivo mouse studies and in-vitro studies.
In-vitro studies have showed that GaRP could reduce the production of pro-inflammatory proteins by more than 85 percent.
Preliminary results of the IBS trial are expected to come out in June.
As for 3FDC, the company will be working with the national institute CSIRO in studying the formulation’s impact on psychological functioning in adults.
The trial is supported by the Innovation Connections Grant, which was awarded to the company via the Australian government’s Entrepreneur’s Programme.
The trial will specifically assess potential improvement in symptoms of anxiety, depression, and stress.
Lydeamore said the research team has been preparing the study protocol and expects to begin the trial this year.