Anatara Lifesciences’ Stage 2 GaRP trial for IBS treatment gains momentum
Recruitment is advancing for Stage 2 of Anatara Lifesciences’ (ASX: ANR) pivotal gastrointestinal reprogramming (GaRP) trial to treat irritable bowel syndrome (IBS).
The five trial sites in Melbourne, Sydney and Brisbane have received more than 500 expressions of interest and have completed the standard screening processes consistent with Stage 1.
Thirteen participants have been enrolled to date, with the company expecting a maximum of 100 enrolments before the end of the next quarter.
Randomised group
Participants will be randomised into one of two arms in a 1:1 ratio and will receive the optimum dose of GaRP or a placebo over the trial’s 10-week duration.
Anatara said the Stage 2 trial is “sufficiently powered” to deliver statistically significant results versus placebo.
Eligible participants can still register interest using a link on the Anatara website.
Confirmation sought
Stage 2 of the GaRP-IBS clinical trial aims to confirm “highly encouraging and clinically meaningful” interim results from Stage 1 that are believed to have signalled a “promising new era” in the quest to alleviate the burdens of IBS and related disorders.
Data from both stages of the trial will form the basis of analysis.
Confirmation of these results is expected to provide an evidence-based claim to distinguish GaRP as an IBS treatment.
It will provide Anatara with a valuable foundation to engage with global pharmaceutical companies in delivering a new treatment for IBS into a “highly unsatisfied” market.
The company is also investigating potential uses of its established products and know-how for application in the area of animal health.
Complementary medicine
GaRP is a multi-component, multi-coated complementary medicine designed to address underlying factors associated with chronic gastrointestinal conditions such as IBS and inflammatory bowel disease.
It is designed to assist in the restoration and maintenance of the gastrointestinal tract lining as a barrier and assist the homeostasis of the microbiome.
The product is made of GRAS – generally regarded as safe – components.