Gastrointestinal diseases specialist Anatara Lifesciences (ASX: ANR) has report good progress with recruitment for the second stage of its pivotal GaRP-IBS (Irritable Bowel Syndrome) trial.
The company said there have been high levels of interest shown at all five sites situated in Melbourne, Sydney and Brisbane with a total of over 500 Expressions of Interest (EoI) to date.
Following the trial protocol screening processes, consistent with Stage 1 of the trial, enrolments have already begun with 13 participants currently randomised. This is in line with company expectations following a slight administrative delay at some of the new trial sites.
The target participant number is 60-100 for Stage 2 of the trial and the company anticipates this target number will be met in Q3 CY2024 with Headline Results readout anticipated Q4 CY2024, in line with previous guidance.
Potential participants can find the closest site to register their interest in Stage 2 of the clinical trial via the Company’s website: https://anataralifesciences.com/garp-clinical-trial/
Participants will be randomised into one of two arms in the trial in a 1:1 ratio and receive either the optimum dose of the GaRP product selected from Stage 1 or placebo for eight weeks plus two week follow- up.
Stage 2 aims to confirm the highly encouraging and clinically meaningful interim results from Stage 1 of the GaRP-IBS clinical trial. The data from Stage 1 and the 60-100 Stage 2 patients in the randomised, placebo controlled, double blind trial will form the basis of the analysis. This will result in approximately 100-140 patients in total. The trial is sufficiently powered to deliver statistically significant results versus placebo.
Ongoing corporate initiatives
The results to-date have signalled a promising new era in the quest to alleviate the burdens of IBS and related disorders. Confirmation of these results will provide the desired evidence-based claim to distinguish GaRP as an IBS treatment and a more valuable foundation to engage with global pharma companies interested in expanding their portfolio of complementary medicines. Discussions remain ongoing with potential partners interested in delivering a new, safe and effective treatment for IBS into a highly unsatisfied market.
Additionally, the company continues to actively assess other opportunities in the human healthcare space and is appraising projects suitable to add to the company’s portfolio. There are also ongoing discussions for potential uses of Anatara’s established products and know-how for animal health.
About GaRP
Anatara’s GaRP product is a multi-component, multi-coated complementary medicine designed to address underlying factors associated with chronic gastrointestinal conditions such as IBS and IBD.
GaRP is the working name for the product from the company’s Gastrointestinal ReProgramming project that was designed to assist restoration and maintenance of the gastrointestinal tract (GIT) lining as a barrier and assist the homeostasis of the microbiome. The product is made of GRAS (Generally Regarded As Safe) components.