Reports Statistically Significant Animal Studies
Brisbane, Oct 14, 2019 AEST (ABN Newswire) - Anatara Lifesciences Ltd (
ASX:ANR) is pleased to report statistically significant efficacy data from its in vivo mouse studies and further positive in vitro proof of concept data for its Gastrointestinal ReProgramming (GaRP) product. GaRP is a proprietary dietary supplement designed to restore and maintain a healthy human gut and microbiome.
Highlights
- Successful completion of the preclinical program has provided strong scientific proof that the GaRP dietary supplement has the potential to be game changing
- When compared to a placebo control, GaRP reduced the combined disease characteristics of colon inflammation and disrupted bowel habits by 2.5-fold (p=0.012)
- Promoted mucosal healing by increasing mucin genes by a factor of 5 to 7-fold (MUC2 and MUC6, p<0.001)
Anatara's lead human health product, GaRP, is being developed to specifically target two human gastrointestinal (GI) disorders, Inflammatory Bowel Disease (IBD), including ulcerative colitis and Crohn's disease, and Irritable Bowel Syndrome (IBS). 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 perceive the risk-benefit of CAMs to be favourable, patients are willing to spend significant amounts of money on these therapies. In 2018, expenditure on gastrointestinal supplements and over-the-counter (OTC) digestive remedies in the US alone was US$8 billion.
The current treatment approach with IBD is to suppress the inflammation with the goal of inducing and maintaining remission, while in the case of IBS, gastroenterologists primarily treat the symptoms of abdominal pain, bloating and alternating constipation and diarrhoea. These therapeutic approaches have high treatment failure rates. Consequently, there is a significant unmet medical need for products that can i) re-establish the homeostasis of the microbiome, ii) treat the inflammation and iii) repair the mucosal damage, which will in turn have the downstream effect of reducing disease-associated diarrhoea.
During preclinical development of the GaRP dietary supplement, the proprietary formulation has provided strong scientific evidence that it can combat the three underlying causes of chronic bowel conditions. In summary, GaRP:
- Addressed the dysbiosis of the microbiome by inhibiting the attachment and invasion of pro- inflammatory bacteria (obtained from IBD and IBS patients) into healthy gut cells by >95% (p=0.002).
- Reduced gut inflammation by 85% by significantly reducing the production of proinflammatory proteins, p<0.001). Daily treatment with GaRP demonstrated a therapeutic benefit by significantly reducing the key disease indicators of colitis in mice. When compared to a placebo control, GaRP reduced the combined disease characteristics of colon inflammation and disrupted bowel habits by 2.5-fold (p=0.012).
- Promoted mucosal healing by increasing mucin genes by a factor of 5 to 7-fold (MUC2 and MUC6, p<0.001). These genes have been shown to be significantly reduced in both IBD and IBS patients. Through increasing the genes, it is expected that the proteins which produce gut protecting and healing mucins will also increase, which in turn may promote mucosal healing.
Anatara anticipates initiation of human clinical study activities in late 2019, with a view to partnering in the second half of calendar 2020.
Anatara's CEO, Mr Steven Lydeamore said, "The successful completion of the preclinical program has provided strong scientific proof that the GaRP dietary supplement has the potential to be game changing. Our proprietary over-the-counter product has demonstrated that it not only has the potential to manage the symptoms of IBD and IBS patients, but may also reduce the underlying causes of these chronic bowel conditions. This is a major milestone for Anatara's GaRP development program bringing us closer to partnering."
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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