Anatara Lifesciences (ASX: ANR) has received Human Research Ethics Committee (HREC) approval to undertake a clinical trial of its Gastrointestinal Re-Programming complementary medicine (GaRP) in participants with irritable bowel syndrome – diarrhoea subtype (IBS-D).
Ethics approval is confirmation Anatara has completed the necessary pre-clinical safety and efficacy testing of GaRP required to commence human clinical studies. Now that HREC approval of the protocol has been received, we are able to immediately undertake site initiation procedures a prerequisite for patient recruitment which is planned for March 2021.
Anatara’s GaRP complementary medicine is being developed to specifically target two human gastrointestinal disorders, irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). IBS is the most common GI condition affecting approximately 11% of the global population while IBD affects an estimated five million people globally.
CEO, Steve Lydeamore, said the randomised, double-blind, placebo-controlled study will be conducted in two stages as a virtual study using ObvioHealth Australia’s ClaimIt platform. This involves minimal on-site visits and participants completing most assessments online.
Up to six sites will be established by Sonic Clinical Trials and approximately 200 participants enrolled. GenesisCare Clinical CRO will provide medical advisory and medical monitoring services whereas Microba will provide microbiome testing using shotgun metagenomic sequencing and proprietary bioinformatics.
The study design consists of two stages (Stage 1, Stage 2), with an interim analysis between stages.
There is a major unmet need and significant market opportunity for an evidence-based complementary medicine for IBS,” Mr Lydeamore said.
“Human ethics approval is another milestone for Anatara and clinicians and patients seeking effective remedies to address IBS.
“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.”
