Adelaide, Australia, 28th Dec 2024 – Anatara Lifesciences has been working towards the release of a new complementary medicine for IBS sufferers. Anatara’s GaRP-IBS trial has progressed to Stage 2, with Stage 1 showing strong preliminary efficacy results. Patients on the low dose saw a 56% reduction in IBS-SSS scores, outperforming the placebo group by 20%. Promising news for IBS sufferers!
Now recruitment of Stage 2 has hit a huge milestone this week!
This interview with Executive Director Dr. David Brookes discusses this exciting phase in GaRP’s development.
Q. Can you share the latest developments in Anatara’s GaRP-IBS clinical trial, particularly with the recent addition of sites in Adelaide and the Sunshine Coast?
Dr. Brookes: I was able to update on the trial in the recent ASX announcement on the 4th of December and at a webinar the following day that enrolment had reached approximately 60 with more than a further 25 involved in advanced screening. The trial’s momentum has been maintained with the new sites being important contributors. Stage 2 of the GaRP-IBS Phase II trial was designed with an anticipated minimum of 60 participants which we are pleased to be meeting and anticipate passing comfortably. Hence, the Company has announced a halt on recruitment from the 13th of December.
Q. How have participant enrollments been progressing across all trial locations, and what does this mean for the overall study timeline?
Dr. Brookes: The enrolments have continued across the 4 active sites at a rate that has allowed us to halt recruitment from the 13th of December as enrolments pass the anticipated minimal number of participants with a focus on a headline results readout early next year (1QCY25).
Q. What unique advantages did the new trial sites in Adelaide and the Sunshine Coast offer for expanding Anatara’s reach to a broader patient base?
Dr. Brookes: Both SAHMRI in Adelaide and CDHRI up in Queensland offered not just a new geographical area for IBS sufferers interested in access to the trial but also the required empathy for the difficulties of the condition and the trial requirements.
Q. From your perspective, what are the key unmet needs in gastrointestinal health, and how does GaRP-IBS aim to address them?
Dr. Brookes: It is easiest to answer this in 2 components, so taking IBS firstly, there are no products currently available that offer both symptomatic relief and ongoing control of this difficult condition and GaRP has the potential to demonstrate being able to do that by, and if, the Stage 2 trial results are consistent with Stage 1. Secondly, there is increasing recognition of the importance of the lining of the gastro-intestinal tract (GIT) as a barrier for overall health considerations and management of many conditions relating to the inherent complexities of the GIT that include the homeostasis of the microbiome. Yet there are no specific therapies for restoration and maintenance of this barrier despite the importance of the functionality to conditions such as IBD & IBS and considerations such as the gut-brain axis.
Q. How does Anatara approach patient-centric design in clinical trials, especially for chronic conditions like IBS that significantly impact quality of life?
Dr. Brookes: QoL (Quality of Life) is an ever-present consideration to both managing the practicalities of trial participation and measuring the success of the medication that is the focus of a trial. If the active ingredient is providing a therapeutic effect and not causing any significant side-effects, then you would expect QoL to improve which is part of the reason we include measures of QoL and emotive considerations ( anxiety/ depression) in our secondary endpoints.
Q. Can you discuss any challenges or insights gained from the earlier stages of the GaRP-IBS trial that are informing the current phase?
Dr. Brookes: The Company had to learn the hard way, after pushing on with the trial during the COVID period in 2020, that the participants with the difficult disorder of IBS need open and available support and reassurance. We also modified, with approval via the appropriate ethics process, some of the inclusion/exclusion criteria without affecting the trial quality to make the overall process more participant-friendly.
Q. Looking at the broader GI health landscape, what emerging trends or innovations are most relevant to Anatara’s vision and product pipeline?
Dr. Brookes: There is increasing awareness worldwide of the importance of the complexities of gastrointestinal health in general, including emotional well-being and immune robustness. The homeostasis of the microbiome is “populist” and an important component in that, with GaRP’s multi-coated, multi-component formulation designed to assist that homeostasis. However, the microbiome can not be considered in isolation as the integrity of the gut wall lining as a barrier is key to many complex interactions. GaRP is also specifically designed to restore and maintain this lining as a treatment target.
Q. How does Anatara balance scientific innovation with the commercial considerations of developing and launching a successful product in this space?
Dr. Brookes: The Anatara team enjoys continually assessing opportunities even though, as you’d probably guess, most are not able to be progressed. We apply a strict evidence-based approach such as demonstrated by the GaRP-IBS randomised, double blind trial and are not interested in products that are really often differentiated only by marketing.
Q. As you look toward the trial’s completion, what are the most promising outcomes that could emerge from the GaRP-IBS study?
Dr. Brookes: The trial has been conducted so that if a positive readout from Stage 2 corroborates Stage 1 then the GaRP product will be differentiated by evidence for an understood mechanism of action that relieves and controls IBS, which is a condition that overlaps considerations in other gastrointestinal or related conditions. So the outcomes are a new treatment option for IBS sufferers based on gold standard medical rigour and a number of other indications for the use of GaRP medication such as IBD (Inflammatory Bowel Disease), FD (Functional Dyspepsia) and a range of considerations around the “leaky gut syndrome” and the gut-brain axis.
We look forward to hearing more about this exciting new phase in the GaRP clinical trial. For more information, head to ibstrial.au.
Media Contact
Organization: Anatara Lifesciences
Contact Person: Dr David Brookes
Website: https://anataralifesciences.com/
Email: Send Email
City: Adelaide
Country: Australia
Release Id: 28122421306