Shining a Spotlight on IBS: Anatara Lifesciences Makes Strides in Phase II Trial during IBS Awareness Month

Topic:

April was IBS Awareness Month, dedicated to shedding light on a condition that affects millions worldwide.

ADELAIDE, SOUTH AUSTRALIA / ACCESSWIRE / July 9, 2024 / In Australia alone, statistics reveal the profound impact of Irritable Bowel Syndrome (IBS) on individuals and the economy. With 1 in 7 Australians affected by IBS, predominantly females at a ratio of 2:1 to males , the condition exerts a significant toll. Notably, IBS costs the Australian economy 1.5 billion annually, underscoring the urgency of advancing treatments and raising awareness. The majority of IBS sufferers are not satisfied with their current prescription or OTC ( "over the counter") medications.

Pictured - Anatara's RMH (Royal Melbourne Hospital) trial site, one of two sites in Melbourne

Anatara Lifesciences (ASX: ANR) has initiated Stage 2 of the Phase II GaRP-IBS trial, a significant milestone following the highly encouraging findings from Stage 1 in late 2023. The interim analysis following Stage 1 demonstrated promising results, meeting all endpoints and signaling a potential new era in addressing the burdens of IBS and related disorders.

Prospective participants interested in Stage 2 can register their interest via the Company's website. anataralifesciences.com

"The 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," said Dr. David Brookes, Executive Chair Anatara Lifesciences (ASX: ANR).

The GaRP ("Gastrointestinal ReProgramming") is a multi-component, coated complementary medicine meticulously designed to tackle gastrointestinal (GIT) conditions such as IBS and Inflammatory Bowel Disease (IBD). GaRP, as the product developed from Anatara's Gastrointestinal ReProgramming project, has the promise to revolutionise IBS treatment and many other GIT conditions. Comprised of Generally Regarded As Safe (GRAS) components, GaRP's unique mechanism of action is designed to restore and maintain the gastrointestinal tract (GIT) lining and microbiome homeostasis, offering a novel approach to managing IBS by both relieving symptoms and addressing underlying causative factors.

The interim analysis of Stage 1, involving 61 Intent-to-Treat (ITT) participants, concluded in September 2023 and successfully met all goals on subsequent analysis. Following the confirmation of both safety and promising efficacy, the trial has now advanced to Stage 2 using the selected Low Dose regimen. This pivotal milestone of Stage 2 recruitment is driven to further the evidence for the potential of GaRP as a transformative IBS treatment option.

The key focus of Stage 2 is the confirmation of GaRP's efficacy in alleviating IBS symptoms at the selected optimum dose. This follows participants receiving both the Low and High Dose regimes in Stage 1 experiencing a notable reduction in symptoms, indicating the product's potential to enhance the quality of life for individuals living with IBS. These findings underscore GaRP's ability to address the multifaceted nature of IBS, offering hope to millions of sufferers worldwide. Not only did both dose regimes from Stage 1 reduce the primary endpoint of IBS symptom scoring by 50% or more, there was also a remarkable, statistically significant reduction in the accepted anxiety and depression scoring scale (HADS) in the Low Dose cohort . This highlights the holistic approach of GaRP towards enhancing overall patient outcomes.

The findings from Stage 1 suggest a potential significant advancement in the field of IBS treatment. By targeting the underlying mechanisms of IBS and restoring gastrointestinal tract (GIT) homeostasis, GaRP represents a paradigm shift in the management of gastrointestinal disorders. The potential implications of GaRP extend beyond IBS, with implications for conditions such as Inflammatory Bowel Disease (IBD) and many other disorders.

As Anatara Lifesciences (ASX: ANR) continues to progress toward commercialisation and regulatory approval, the findings from Stage 2 of the GaRP-IBS trial are anticipated to provide compelling reinforcement of evidence supporting GaRP's efficacy and safety. With further research and development, GaRP has the potential to revolutionize the landscape of gastrointestinal health, offering hope to millions of individuals worldwide suffering from IBS, IBD, FD (Functional Dyspepsia) and other disorders involving the GIT lining .With the complex bi-directional signaling between the GIT and the brain (known as "the gut-brain axis"), the importance of GaRP's mechanism that includes addressing "leakage"from the gut lining and the homeostasis of the microbiome is further highlighted.