Anatara Lifesciences Limited announced to provide an update on the progress of clinical trials in irritable bowel syndrome and psychological functioning. The Company also provides a brief operational update. Human clinical trials for IBS (GaRP) and psychological functioning (3FDC): Globally there is a high prevalence of digestive disorders requiring relief from both symptoms and the disease process, including irritable bowel syndrome (IBS).

There is also increasing interest in the "gut-brain" axis and the influences of the microbiome. The "GaRP" and "3FDC" complementary medicines provide a significant market opportunity to address these considerations whilst improving individuals' quality of life. The leaders of the 3FDC trial are clinical psychologists with a long-term interest and deep understanding of the role of the gut-brain axis as an influence on psychological well-being.

As expected, the facilities were very impressive and incredibly accommodating for trial participants. This randomised, double-blinded, placebo-controlled study, commenced in August 2021, is being conducted in two stages as a virtual study. This involves minimal on-site visits and participants completing assessments online.

Up to 6 sites will be established and approximately 200 participants enrolled. The study design consists of two stages with an interim analysis between stages. Stage 1 is anticipated to be completed early in the 4th quarter of calendar 2022.

Stage 2 is anticipated to be completed in 1st quarter of calendar 2023. Stage 1 will assess safety, tolerability, and be a guide to the efficacy of the two different strengths of GaRP used against a placebo, randomly divided in a protocol of 3 equal groups. Following interim analysis, one dose will be selected, and the remaining participants recruited in a 1:1 randomisation protocol.

Of the 200 planned participants, at least 90 will enrol in stage 1, and 110 participants will enrol in stage 2. For each participant in each stage, the study will last for 12 weeks; including 8 weeks of treatment, preceded by a 2-week screening/baseline period, and followed by a 2-week washout period. Measurements will include a number of surveys including the IBS specific surveys: IBS-SSS (severity scoring system), IBS-AR (adequate relief) and Bristol Stool Form Scale. Other surveys will look at overall well-being, such as the IBS QoL (quality of life) and HADS (Hospital Anxiety and Depression Scale) in recognition of the importance of the gut-brain connection.

The usual and expected clinical markers will all be monitored, including microbiome analysis. Irritable Bowel Syndrome (IBS) is the most diagnosed gastrointestinal condition and a significant burden on healthcare. Over USD 8 billion is spent annually on supplements and OTC digestive remedies in the US alone, presenting a huge market opportunity for Anatara.