Human Health Update
Melbourne, Dec 8, 2020 AEST (ABN Newswire) - Anatara Lifesciences (
ASX:ANR) is pleased to advise that it is planning initiation of a human clinical study on changes to psychological functioning in adults with a moderate level of depression, anxiety or stress symptoms, in response to use of the Company's recently developed colon-targeted formulation (3FDC).
Anatara has been awarded an Innovation Connections Grant, under the Australian Government's Entrepreneurs' Programme, with funding to be provided to the Commonwealth Scientific and Industrial Research Organisation (CSIRO). This planned study is to be conducted at the CSIRO Nutrition and Health Research Clinic in Adelaide, South Australia. An update will be provided once the timeline for the study is finalised.
3FDC is a subset of Anatara's Gastrointestinal Re-Programming (GaRP) complementary medicine and contains ingredients that are known to have broad ranging effects in the gastrointestinal tract and systemically, including modulation of the gut-brain axis. The proposed study is to evaluate whether ANR03 delivered to the colon effects psychological functioning, specifically assessing for potential improvement in symptoms of anxiety, depression and stress.
CEO Steve Lydeamore commented, "In GaRP we have may have a portfolio in a product. During GaRP pre-clinical research, Anatara evaluated ingredients individually and in permutations to evaluate modulation within the gastrointestinal tract of gut dynamics, including immune considerations and the microbiome. Furthermore, the broad ranging effect of metabolites is increasingly considered to influence the so-called gut-brain axis. The proposed psychological functioning study will evaluate anxiety, depression and stress to assess changes to neuroactivity with the use of 3FDC".
Anatara has developed GaRP to address the unmet need for sufferers of IBS (Irritable Bowel syndrome) and IBD (Inflammatory Bowel disease). Anatara anticipates commencing in early 2021 an adaptive, randomised, double-blinded, placebo-controlled virtual clinical trial in IBS. The Company considers that future opportunities for evaluation may include functional constipation, functional diarrhoea and functional dyspepsia. Diagnostic criteria were met for at least one functional gastrointestinal disorder by 40.3% in an international survey.
CEO Steve Lydeamore commented, "As previously announced, Anatara is discussing licensing and commercialisation of GaRP with global consumer health companies. Information about the new potential use of 3FDC, a subset of GaRP, will now be made available to these companies. The revised timeline to a GaRP partnering deal is now H1, calendar 2021. Preliminary results of the GaRP IBS trial are anticipated in June 2021."
Anatara's Gastrointestinal ReProgramming (GaRP) dietary supplement
Anatara's GaRP complementary medicine is being developed to specifically target two human gastrointestinal disorders, irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).
IBS is the most common GI condition affecting approximately 11% of the global population while IBD affects an estimated five million people globally.
Current pharmaceutical treatments have high failure rates and severe side-effects, leading to over 50% of IBS and IBD patients trying complementary and alternative medicines (CAMS) in the hope of effectively managing their chronic bowel condition. As many patients and healthcare providers believe the risk benefit of CAMs to be favourable, patients are willing to invest in their health, with this market segment being significant. In 2018, expenditure on gastrointestinal supplements and OTC digestive remedies in the US alone was US$8 billion.
About Anatara Lifesciences Limited
Anatara Lifesciences Limited (ASX:ANR) is developing and commercialising innovative, evidence-based products for gastrointestinal health where there is significant unmet need. Anatara is a life sciences company with expertise in developing productsfor human and animal health. Anatara is focused on building a pipeline of human gastrointestinal health products. Underlying this product development program is our commitment to delivering real outcomes for patients and strong value for our shareholders.
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