Anatara is developing proprietary bromelain formulations for gastrointestinal health.
Gastrointestinal Reprogramming Product (GaRP)
Introducing GaRP, a microbiome-targeted dietary supplement
Anatara’s GaRP product is a microbiome-targeted multi-component dietary supplement that has been designed to address the primary underlying factors associated with chronic gastrointestinal conditions such as irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).
The causative factors of IBS and IBD are still not fully understood, but genetic predisposition and environmental risk factors appear central to the development of these chronic bowel conditions.
When exploring the pathophysiological mechanisms of IBD and IBS, three common factors emerge:
i. Increased intestinal permeability.
iii. Dysbiosis of the microbiome
Current treatment options for IBS and IBD are limited due to the complex pathophysiology of these conditions and as such, there is a severe unmet clinical need for products that can treat each of these primary underlying factors, and induce and maintain remission in patients.
Our lead product is being positioned as an adjunct to existing therapies, and it will not be replacing current prescription medications. Over the last 20 years the use of dietary supplements as adjuncts to prescription drugs has increased significantly.
GI disorders affect a significant proportion of the population at some stage of their life, with IBS affecting more than 20% of the Australian population.
Approximately 50% of IBS and 30-50% of IBD patients seek additional relief of their symptoms through the use of complementary and alternative medicines (CAMs) – this approach is generally precipitated by the high failure rates and severe side-effects of current prescription therapies. As the role of a dysfunctional gut microbiome and inflammation are central to the initiation and perpetuation of IBD and IBS, there is an urgent need for CAMs that can rectify these underlying conditions
Increased education and more detailed evaluation of dietary supplements and has led to health-care providers working with patients to develop individualised programs which include dietary supplements in the symptom management for GI disorders.
Developing a dietary supplement provides several regulatory and commercial advantages as it is less expensive than prescription medicines and has a less risky pathway to market, thereby accelerating market entry. Both the public and health care professionals alike understand the term ‘dietary supplement’ and with the right partner, marketing can be aimed at both the public and professionals. Unlike pharmaceuticals, demonstrating superiority to other products is not necessary. Marketing, sales, and medical affairs activities encourage health care professionals to recommend products to their patients. Therefore, finding and selecting the best marketing partner is critical to the success of a product such as GaRP and consequently this has and will continue to be a major focus for Anatara.
The design of GaRP has been enabled by leveraging published research in conjunction with the extensive body of knowledge generated in-house at Anatara. Bromelain is one of the main components of GaRP and therefore forms the basis of its acceptability as an effective dietary supplement.
Anatara has been actively working on the development of the GaRP product and has completed the dose selection of each formulation component. The Company has recently generated in vitro data to support the effectiveness of GaRP in:
• Removing bacteria with pro-inflammatory properties;
• Reducing inflammation by reducing the release of pro-inflammatory cytokines;
• Regenerating the integrity of the gastrointestinal tract; and
• Stimulating mucosal healing.
Further information on the proof of concept results can be found here.
Successful GaRP proof of concept studies
Diagrammatic representation of the mechanism of action of Anatara’s GaRP CAM and its ability to collectively overcome the common underlying causes of chronic bowel conditions.
Following successful proof of concept studies for the Company’s gastrointestinal dietary supplement in reducing inflammation and pro-inflammatory gut bacteria, planning is now underway for a human clinical study in IBS patients. Key clinical trial activities such as trial design, product manufacture and clinical research organisation selection have commenced with an expected submission of the ethics application by the end of 2019.
Preceding the human study, mouse pre-clinical studies are due to commence to provide important pre-clinical data for both IBS and IBD.
Further information on our human development plans will be provided in the near future.