Annual Report to Shareholders
An important milestone was achieved in February, when we received ethics approval to commence the human trial for the treatment of a sub-type of irritable bowel syndrome (IBS) using our Gastrointestinal ReProgramming (GaRP) complementary medicine. This randomised, double-blind, placebo-controlled trial will be conducted in two stages as a virtual trial, with minimal on-site visits and participants completing assessments online. The trial will use up to six sites and approximately 200 participants will enrol. Due to a scheduling delay in availability of the placebo from reduced manufacturing shifts under COVID-19 restrictions, recruitment for the trial is now commencing in August 2021 with an interim readout anticipated in March 2022. The trial is anticipated to be completed in September 2022.
In April, we also received approval from the Human Research Ethics Committee to undertake a human trial on the effects of 3FDC dietary supplementation on psychological functioning in adults. This randomised, double-blinded, placebo-controlled study will be undertaken with CSIRO in Adelaide. 3FDC is the Company's name for 3 specific components of the GaRP programme that are coated for delivery beyond the small intestine.
3FDC is targeted to release from the junction between the small and large intestine (ileocecal junction) and exert its effects on the microbiome in the large intestine. The coated delivery of these 3FDC components to the large intestine is considered important for gut-brain axis balance, in part due to influences on microbiome homeostasis and metabolites. The CSIRO will run a clinical trial with 3FDC to observe 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 October 2021. The trial is anticipated to be completed in April 2022.
During the year we substantially progressed our animal health studies, where we are targeting the need for growth enhancement feed products, without antibiotics or zinc oxide.
Our activities prioritised removing barriers to out-licensing Detach(R) through the progression of challenge trials for our piglet and poultry formulations.
In February, we announced the successful completion of the poultry challenge trial testing "Efficacy of ANRpf on the performance of broilers subject to subclinical and necrotic enteritis challenges". ANF-pf is our proprietary enriched formulation for poultry in water, designed to allow the full delivery of key additives in a quick and flexible dosing method. The study was a randomised, placebo controlled trial. The parameters analysed were bird weight gain, feed intake, feed conversion ratio and other complex parameters. The initial results were extremely encouraging, with statistical significance demonstrated across multiple parameters.
Further work to optimise the dose and dosing regimen are required to fully understand the commercial opportunity and the product's value.
The BONIFF-SMEC piglet challenge study for Escherichia Coli commenced in April and was completed in June, at Murdoch University. BONIFF-SMEC is our formulated feed additive in Ridley Corporation's semimoist extruded creep feed for piglets. We were delighted to receive the results of the piglet challenge study in August 2021, which we aim to leverage to partner our bromelain-based animal health portfolio.
Pleasingly, we could conclude that under the conditions of the proof-of-concept study, BONIFF could be considered as a replacement for zinc oxide with commercial levels of additives, in a semi-moist extruded creep (SMEC) piglet diet . While the commercial opportunity here is still being established ,the initial indications are that BONIFF can be added to feed at a significant saving per tonne compared to the current regime of non-physiological levels zinc oxide combined with commercial levels of additives such as organic acids.
Medicinal use of zinc oxide will be banned in Europe from 2022 and Canada recently announced their intent to follow the European Union's lead, which implies that there is a strong, and currently unmet, demand for alternatives. It was highly encouraging that performance (weight gain) was maintained for the BONIFF group, compared to the standard diet.
Patent for Detach(R)
In April, we were granted a patent for our Detach(R) animal health product, which strengthened our intellectual property position in the treatment of, and prevention of, diarrhoea caused by pathogenic microbes. The patent provides the pathway for us to further pursue commercialisation opportunities and expires on 24 August 2038. With scour in piglets being an expensive, debilitating, and in some cases, lifethreatening condition, having a product that is registered for use in Australia places us in a strong position to work towards a commercial deal.
During the year we progressed licensing discussions for GaRP with international consumer health companies. We are highly encouraged by our discussions to date with potential partners, and following the completion of our IBS human trial in September 2022, we expect to be in a really strong position to announce a commercial partnership. There is potential for an earlier partnership if interim results, anticipated in March 2022, indicate a strong trend towards a statistically significant benefit . Given the size of the complementary medicine market for gastrointestinal health products that address a spectrum of symptoms and disorders, the GaRP pipeline can add substantially to the overall shareholder value. Anatara intends to seek licensing agreements and partnerships with established consumer health companies rather than contemplate direct marketing and distribution.
Despite the delays to the commencement of our human trials, we remain in a robust financial position, ending FY21 with cash at bank of $3.4 million (up from $2.7 million on 30 June 2020). Our balance sheet provides significant scope for us to undertake both human trials and pursue initiatives to partner both our human and animal health assets.
During the year to 30 June 2021, the Company made significant steps towards taking its first human gastrointestinal health product, GaRP, to market. Expenditure in furthering this effort resulted in a loss after tax of $1,995,874 for the period (2020: $3,364,644).
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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