Monthly Activities Report
Commenting on the quarter, CEO Steve Lydeamore said, "Anatara is pleased to have made solid progress in obtaining the appropriate approval and grants for our human and animal health products over this period. We are at an exciting phase of Anatara's development, with two human clinical trials now imminent, and a number of pathways being pursued for the commercialisation of both the human and animal products."
"More than ever, the world is looking for safe and effective solutions to gut health. Anatara's progress to-date in developing evidence-based solutions for the sufferers of gut symptoms, including both irritable and inflammatory bowel syndromes, is now focused on the commencement of our human trials. The human clinical trials are the key next step to moving closer to commercialisation and entering the US$8+ billion gastrointestinal supplements and over-the-counter digestive remedies market."
Irritable Bowel Syndrome (IBS) Trial Recruitment imminent
Anatara has strong pre-clinical data to support GaRP use in IBS, the most commonly diagnosed gastrointestinal condition and a significant cost burden on health care. Anatara received Human Research Ethics Committee approval to undertake a clinical trial of GaRP for participants with irritable bowel syndrome - diarrhoea subtype (IBS-D), in February.
The Company has prepared its trial recruitment website which will be launched very soon following Covid related manufacturing delays. GaRP has been manufactured and shipped and the placebo has been coated and is presently being packaged. Recruitment for both GaRP and 3FDC clinical trials are anticipated to commence during the next quarter.
Ethics approval to start Psychological Functioning Trial in adults
Anatara announced in April that it had received Human Research Ethics Committee approval to conduct a clinical trial with CSIRO on the effect of 3FDC dietary supplementation on psychological functioning in an adult population.
3FDC is one of the components of Anatara's GaRP dietary supplement with a method of action in the large intestine. One aspect is to assist the homeostasis of the microbiome which is considered important for the "gut-brain axis" balance. The 3FDC components have been selected to explore their effects on depression, anxiety and stress symptoms in otherwise healthy individuals.
The CSIRO team will develop the work guidelines and initiate recruitment with the aim of dosing the first participants in the third quarter of calendar year 2021. Recruitment is anticipated to begin from September 2021.
Australian patent grant for Detach(R)
In April Anatara announced the grant of patent number AU2019204496 entitled "Anti-diarrhea formulation which avoids antimicrobial resistance".
Anatara's animal heath product, registered in Australia as Detach(R), uses the patent as a non-antibiotic approach to aid in the control of diarrheal disease (known as "scour" which can be a debilitating and, in some cases, life-threatening condition ) developed using bromelain, an extract from pineapple stems.
The patent claims cover an oral formulation of bromelain effective to treat and prevent diarrhea caused by pathogenic microbes. This formulation does not kill pathogenic microbes, and thus does not facilitate the proliferation of anti-microbial resistant organisms. The patent is fully owned by Anatara and will expire on 24 August 2038.
The patent provides the pathway for Anatara to further pursue commercialisation opportunities for Detach(R).
BONIFF piglet challenge study
To address piglet scour, which is estimated to cost the Australian pig industry more than $7 million per year, Anatara and Ridley initiated a weaner piglet challenge study, utilising Anatara's bromelain-based formulation (BONIFF). The study was conducted by Murdoch University, with funding from the Australasian Pork Research Institute Ltd.
Murdoch University has completed dosing in the study which tested a modified formulation of BONIFF in Semi-Moist Extruded Creep (SMEC) feed on weaning piglets under an enterotoxigenic Escherichia coli (ETEC) challenge model, to determine the efficacy of this combined formulation on piglet health, welfare, and performance after weaning. The outcome of this study will be announced upon completion of the study report, which is expected in the very near future.
Subject to successful results, discussions will commence with pig producers and animal feed/nutrition companies.
Summary of Q4 FY21 cashflows
The Company's cash plus term deposits at the end of the quarter stood at $3.42 million (31 March 2021: $3.96 million), which comprised cash at bank of $1.72 million and $1.7 million in term deposits.
Net cash outflow during the quarter was $0.52 million. Staff, Admin and Corporate cash outflow of $0.48 million was 7% lower than the prior quarter.
Aggregate payments to related parties and their associates during the quarter was $79,000 which includes directors' fees and superannuation.
Near term operational milestones
Over the next 6-12 months, the Company is aiming to:
- Sign a commercial agreement for one or more of Anatara's health products
- Commence recruitment for the clinical study with GaRP in IBS patients;
- Commence recruitment of the clinical study with 3FDC in adult participants with moderate anxiety, stress or depression
"With an active program in place over the next 6 to 12 months, including the pursuit of partnership agreements, we are well placed to advance the commercialisation of our current health products", concluded Mr Lydeamore.
To view the cashflow report, please visit:
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 products for animal and human 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. For more information, please visit www.anataralifesciences.com.
Anatara Lifesciences Limited