Anatara Lifesciences (ASX: ANR) a developer of evidence-based solutions for gastrointestinal diseases in humans and animals, is making good progress on the Gastrointestinal ReProgramming (GaRP) trial for IBS.
GaRP – Irritable Bowel Syndrome (IBS) – Last Patient Dosed
Anatara’s GaRP product is a multi-component, coated complementary medicine designed to address underlying factors associated with chronic gastrointestinal conditions such as IBS and IBD. The product is made of GRAS (Generally Regarded As Safe) components and is designed to assist restoration and maintenance of the gastrointestinal tract (GIT) lining and the homeostasis of the microbiome.
As announced in June, a preliminary statistical analysis of the cohort of the initial 31 patients in the GaRP-IBS trial was conducted. The DSMB (Data Safety Monitoring Board) reviewed the preliminary data and were satisfied that the continuation of the current trial protocol was supported, noting the small data set. Importantly, there were no safety concerns across the participant groups.
This feedback encouraged the company to proceed with the ongoing Stage 1 of the trial and commence planning for Stage 2.
Recruitment for Stage 1 was finalised in June with approximately 70 patients from the more than 2,700 applicants screened for enrolment. The GaRP-IBS trial is powered to deliver results that will validate and support efficacy claims.
The trial enrolled males and females 18-65 years of age with irritable bowel syndrome (IBS-SSS score of 175-350) for 12 weeks within which the patients were dosed orally twice daily for eight weeks.
The trial has been designed to return, if successful, a clinically meaningful and statistically significant result, with primary endpoints of a reduction in the IBS-SSS (Irritable Bowel Severity Scoring System) and safety. Secondary endpoints include quality of life, anxiety and depression and pain improvements.
The company is very pleased to have reached the analysis step following the protracted circumstances completing Stage 1,” Anatara’s executive Chair, Dr David Brookes, said.
“The trial was more challenging than anticipated for many reasons and highlighted the difficulties that sufferers of IBS deal with from day to day.
“The trial design will deliver an evidence-based result and the criteria excluded ‘milder’ IBS sufferers (IBS-SSS<175) which meant all participants were IBS patients with significant symptoms to manage and cope with, yet they accepted the challenge of potentially being randomised to a placebo. I take this opportunity on behalf of the company to thank all those who were involved in the trial process.”
GaRP presents itself as a potential disease-modifying treatment that aims to positively impact a large proportion of the population that suffer from the debilitating symptoms of digestive disorders, including irritable bowel syndrome (IBS). The lack of efficacious digestive treatments amplifies the clear unmet need and the significant market opportunity for Anatara. The commercial opportunity for non-prescription products for gastrointestinal disorders and IBS is US$8 billion in the US.
