Anatara Lifesciences progressing towards its first human clinical studies; discussions with potential partners ongoing
Q3 FY21 Activities Report
Commenting on the quarter, CEO Steve Lydeamore said, "Anatara is pleased to have successfully progressed two key milestones during the period - a successful trial for Anatara's proprietary enriched formulation for poultry in water, and ethics approval to start the human IBS trial.
"Anatara now has approval to commence two separate human trials for its Gastrointestinal Re-Programming complementary medicine (GaRP), and there appears to be a wider appreciation of the Company's human health initiatives and the potential to improve overall human wellbeing with a market differentiating focus on evidence based complementary medicine.
"We also remain very encouraged by the progress we are making in the animal health areas, particularly in targeting the need for feed products for growth enhancement that avoid the use of antibiotics or zinc oxide."
Successful completion of poultry challenge trial
In February Anatara announced the successful completion of the poultry challenge trial "Efficacy of ANR-pf on the performance of broilers subject to subclinical and necrotic enteritis challenges". ANR-pf is Anatara's proprietary enriched formulation for poultry in water, designed to allow the full delivery of key additives in a quick and flexible dosing method on-farm even when stock illness is a concern.
Necrotic enteritis (NE) in broiler chickens is a common disease found in all poultry-growing areas of the world which can be controlled by antibiotics. However, with a European ban and worldwide phasing-out of in-feed antibiotics, the focus on alternative strategies has increased to secure chicken health, representing an attractive opportunity for Anatara's formulation.
The commercial significance of the trial is currently being evaluated by animal feed companies and poultry producers.
Ethics approval to start IBS Trial
In February Anatara announced that it had received Human Research Ethics Committee approval to undertake a clinical trial of its Gastrointestinal Re-Programming complementary medicine (GaRP) of participants with irritable bowel syndrome - diarrhoea subtype (IBS-D).
Anatara has now completed the necessary pre-clinical safety and efficacy testing of GaRP required to commence human clinical trials. Recruitment for the trial is planned to begin in May.
IBS is the most commonly diagnosed gastrointestinal condition and a significant cost burden on health care, yet there are limited pharmacological treatment options and symptoms are not well controlled.
Anatara has strong pre-clinical data to support use in IBS, and the human trials are the key next step to moving closer to commercialisation, and tapping into the US$8+ billion gastrointestinal supplements and over-the-counter digestive remedies market.
Post-balance date developments
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, Detach(R), uses the patent as a non-antibiotic approach to aid in the control of diarrheal disease (known as scour), 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).
Ethics approval to start Psychological Functioning Trial in adults
In April Anatara advised that it had received Human Research Ethics Committee approval to undertake a clinical trial on the effects of 3FDC dietary supplementation on psychological functioning in an adult population, in collaboration with CSIRO.
3FDC is one of the components of Anatara's GaRP dietary supplement that exerts its effects on the microbiome in the large intestine. Since restoration of a healthy microbiome is considered important for gut-brain axis balance, the 3FDC components have been selected to explore their effect 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 take 6 months after which data analysis will be undertaken prior to final reporting.
Summary of Q3 FY21 cashflows
The Company's cash plus term deposits at the end of the quarter stood at $3.96 million (31 December 2020: $3.68 million), which comprised cash at bank of $1.46 million and $2.5 million in term deposits.
A positive net cash inflow during the quarter of $0.32 million was due to the R&D Tax Incentive of $0.89 million received, and lower R&D cash outflow due to timing of expenditure on the GaRP clinical trial. Staff, Admin and Corporate cash outflow was lower than the prior quarter by 11%.
Aggregate payments to related parties and their associates during the quarter was $73,000 which includes directors' fees and superannuation.
Over the next 6 months, the Company is targeting to:
- Complete the BONIFF-SMEC piglet challenge study for enterotoxigenic Escherichia Coli
- 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
- Announce a partnering deal for GaRP
"More than ever, the world is looking for safe and effective solutions to gut health. The early progress that Anatara has achieved in developing evidence based solutions for gastrointestinal diseases in both animals and humans is very encouraging. We have a very active program in place over the coming 6 to 12 months to progress the commercialisation of our health products, including pursuing a potential partnership agreement. We remain very encouraged about Anatara's future prospects.", concluded Mr Lydeamore.
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About Anatara Lifesciences Ltd
Anatara Lifesciences (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 Ltd