Anatara Lifesciences (ASX:ANR) has met the projected milestone to finalise a draft protocol for a human clinical trial for its GaRP dietary supplement in the treatment of irritable bowel syndrome (IBS).
CEO, Steven Lydeamore said Anatara has commenced the process of selecting a clinical research organisation (CRO) to undertake the clinical trials.
“There is a major unmet medical need and significant market opportunity for an evidence-based dietary supplement for IBS,” Mr Lydeamore said.
Meeting this milestone keeps Anatara on track to commence this human clinical trial 2Q 2020.”
GaRP is being developed to specifically target two human gastrointestinal (GI) disorders, 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.
Mr Lydeamore said current pharmaceutical treatments have high failure rates and severe side-effects, leading to over 50% of IBS and IBD patients trying complementary and alternative medicines (CAMS) in the hope of effectively managing their chronic bowel condition.
“As many patients and healthcare providers believe the risk benefit of CAMs to be favourable, patients are willing to invest in their health with this market segment being significant.
“In 2018, expenditure on gastrointestinal supplements and over-the-counter (OTC) digestive remedies in the US alone was US$8 billion.
Antara’s GaRP is a natural daily supplement that provides a unique and proprietary combination of clinically studied ingredients to deliver a wholistic approach to gut health. It was specifically developed to improve and maintain gastrointestinal health and assist IBD and IBS patients manage their disease and the associated symptoms.
Mr Lydeamore said it achieves this by:
- Restoring balance to the gut microbiome, which can improve digestive function and boost the immune system;
- Reducing gastrointestinal inflammation, delivering natural digestive support and providing ongoing gastrointestinal aid to help reduce digestive discomfort, better digest food and improve nutrient absorption;
- Promoting and supporting mucosal healing which in turn protects the lining in the gut;
- Restoring intestinal epithelial barrier integrity.