Anatara Lifesciences (ASX: ANR) has initiated Stage 2 of a Phase II gastrointestinal re-programming (GaRP) trial to treat patients with irritable bowel syndrome (IBS).
The milestone follows “highly encouraging” findings from Stage 1 of the trial, whereby 61 intent-to-treat participants were given low- and high-dose regimens of the medication.
Stage 1 of the trial was reported to have met all safety and efficacy endpoints, with a notable reduction in symptoms indicating the potential of Anatara’s GaRP product to enhance the quality of life for millions of people worldwide who live with IBS.
Holistic approach
There was also a statistically significant reduction in the accepted anxiety and depression scoring scale among the low-dose cohort, highlighting the holistic approach of the “GaRP” mechanism of action towards enhancing overall patient outcomes.
Executive chair Dr David Brookes said the trial signalled a potential new era in addressing the burdens of IBS and related disorders.
“This trial is beginning to show that we have developed a product with the promise to be the most complete IBS over-the-counter complementary medicine in the world. The early results suggest that the GaRP product both relieves symptoms and provides ongoing control for sufferers which is consistent with the design and pre-clinical work.”” he said.
Stage 2 of the Phase II GaRP trial will be fully funded by Anatara.
Complementary medication
GaRP is a multi-component and coated complementary medication designed to tackle gastrointestinal conditions such as IBS and inflammatory bowel disease (IBD).
Its unique mechanism of action has been designed to restore and maintain the gastrointestinal tract lining and microbiome homeostasis, offering a novel approach to managing IBS by relieving symptoms and addressing underlying causative factors.
The GaRP-IBS trial follows a traditional pharmaceutical design as a double blind, randomised study to provide quality evidence -based efficacy data with the potential to set the product apart from so many other product claims in the difficult gastrointestinal health space.
Low-dose regimen
Stage 2 of the GaRP trial will use the “low-dose” regimen selected from Stage 1 to confirm the medication’s efficacy in alleviating IBS symptoms.
“The findings are anticipated to provide compelling reinforcement of evidence supporting GaRP’s efficacy and safety,” Dr Brookes said.
“With further research and development, we believe GaRP has the potential to vastly improve the landscape of gastrointestinal health, offering hope of an adjunctive therapy for millions of individuals worldwide who suffer from the wide range of disorders of the gastrointestinal lining, including IBS and IBD.”
Broad and costly impact
IBS is a complex condition commonly referred to as a functional gastrointestinal disorder with a number of underlying causative factors including inflammation.
Statistics show that one in every seven Australians experiences symptoms at some time, which can often be chronic and unpredictable.
They include abdominal pain, bloating, and diarrhoea or constipation. IBS affects more women than men, and the onset of symptoms tends to occur in early adulthood.
The condition is reported to cost the Australian economy around $1.5 billion a year, underscoring the need to bring new treatments to the market.
Current options include laxatives or anti-diarrhoea medications, anti-spasmodic drugs to ease cramping, tricyclic antidepressants to treat pain, bloating, and bowel frequency and cognitive behavioural therapy and gut-directed hypnotherapy.
Capital raising
Anatara received firm commitments from institutional and sophisticated investors last month for a placement priced at $0.04 per share to raise $1 million.
Proceeds will be used to refine the development of GaRP towards commercial manufacturing and strengthen Anatara’s balance sheet to advance prospective licensing negotiations with pharmaceutical companies.
Dr Brookes and non-executive director John Michailidis have committed to $60,000 and $10,000 worth of placement shares, respectively.