Anatara Lifesciences (ASX:ANR) has announced further data from the interim analysis of stage one of its Gastrointestinal ReProgramming (GaRP) trial for irritable bowel syndrome (IBS).
The company said an analysis of the secondary endpoints of the change from baseline in the Hospital Anxiety and Depression Score (HADS) and the change in the Quality of Life for IBS sufferers (IBS QoL) showed marked improvement for patients on the low dose.
"The HADS reduction was highly significant for the Low Dose cohort across anxiety and depression versus placebo whilst the QoL showed an expected trend to improvement for the Low Dose," said the company.
"Stage 1 analysis of the cohort of participants on Low Dose previously showed an improvement from the baseline in the internationally recognised Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) of 56% reduction after 8 weeks treatment (the high dose returned a 50% reduction). The Low Dose cohort outperformed the placebo group by approximately 20% over the 8 weeks of treatment," it said.
The company said it believes the results highlight the need to explore the process of registration of GaRP in Australia and other jurisdictions as a clinically validated IBS treatment.
Anatara’s executive chair, Dr David Brookes, said, “This is further very encouraging data. GaRP is a product with a method of action (MOA) that has the potential to improve mood and quality of life for patients with gastrointestinal tract (GIT) disorders by influencing the complexities of the gut-brain axis through restoration and maintenance of the integrity of the GIT lining and assisting the homeostasis of the microbiome.
"While we anticipated that the quality-of-life scores would and should mirror the previously announced improvement in the primary endpoint of the IBS-SSS, the highly significant improvement in anxiety and depression scores on Low Dose is really pleasing while noting and cautioning the small numbers."
Dr Brookes added, "This analysis of these GaRP-IBS trial Stage 1 secondary endpoints furthers a belief that this complementary medicine’s rejuvenating gastrointestinal tract (GIT) effects will provide relief for sufferers of non-specific GIT symptoms and be an important adjunctive therapy in mainstream medical indications, such as IBS and IBD (Inflammatory Bowel Disease)."