Irritable Bowel Syndrome (IBS) impacts around one in five Australians at some point in their life. IBS-D, a diarrhea prominent subtype of the condition, has no current definitive cure.
Anatara have commenced recruitment for a phase 1/2 clinical trial of their Gastrointestinal Re-Programming complementary medicine (GaRP).
Microba will apply its high-resolution gut microbiome analysis platform to measure the effect of the treatment on the microbiome by comparing pre-treatment specimens and specimens taken after eight weeks on the GaRP complementary medicine.
Anatara has a particular interest in this data as one of the mechanisms of action of the treatment addresses dysbiosis (microbiome disruption) to rebalance a healthy microbiome for sufferers of this condition.
Approximately 200 patients will be enrolled across Queensland, New South Wales, Victoria and Western Australia.
The study is randomised, double-blind and placebo-controlled, and will be conducted in two stages as a virtual study.
Microba’s head of research partnerships, Dr Kylie Ellis, said the project was a step forward in addressing an unmet clinical need for IBS-D sufferers.
“We're excited to work with an emerging Australian biotech company to enable them to generate high-quality data for their new product,” she said.
“Working together, we hope to advance our mission of empowering life-changing innovations in human health through precise analysis of the gut microbiome.”
Anatara CEO Steven Lydeamore said that the trial would evaluate the safety and efficacy of GaRP for future use as a complementary medicine for sufferers of IBS-D.
“There is a major unmet need and significant market opportunity for an evidence-based complementary medicine for IBS,” he said.
“Anatara’s GaRP has demonstrated that it has the potential to manage the devastating symptoms experienced by IBD and IBS patients, by addressing processes that contribute to the pathophysiology of these chronic bowel conditions.”