Argenica (ASX:AGN) advancing ARG-007 to Phase 2

Argenica Therapeutics is moving on Phase 2 for ARG-007, the company’s novel therapeutic developed to reduce brain tissue death after stroke and has submitted its ethics application to St Vincent’s Hospital in Melbourne to begin the next stage of development.

A decision is expected by mid-September, backed by national body the Australian Stroke Foundation and endorsed by the Australasian Stroke Trials Network, the key trial body of Australia.

Given its submission is through the National Mutual Acceptance Program, Argenica only need to submit its application to one Human Research Ethic Committee to gain approvals across multiple Australian hospitals.

Developed by leading UWA researchers and the Perth-based Perron Institute, ARG-007 has been shown to reduce brain tissue death by up to 70 per cent after a stroke, and Phase 1 trials of ARG-007 concluded with all doses judged as safe and well-tolerated. Given the early success, Argenica swiftly secured the backing for Phase 2 trials of a treatment with potential applications for a range of neurological impairments.

Vials of ARG-007 are already being manufactured, allowing for patient recruitment to begin early next year, and Argenica has engaged several global leaders in research, including internationally recognised stroke researcher Professor Graeme Hankey as the trial’s National Coordinating Principal Investigator.

Life sciences clinical research consultancy Alitha Life Science will also be assisting, with Director Tina Soulis and project manager Jane Taylor, both accomplished authorities in their field, working directly with Argenica Head of Clinical Development Dr Meghan Thomas.

Global Clinical Research Organisation ProPharma will also provide critical support services for the trial, bringing together a collection of eminent Australian authorities to tackle what is understated as a serious brain issue for a multitude of sufferers.

A national health issue

An estimated 387,000 Australians aged over 15 have suffered a stroke at some stage, and it has been gauged that there are over 100 stroke events in Australia every day, presenting a significant health issue for older age groups, with more than two-thirds of sufferers aged 65 or over.

Given its standing as a national health issue, Argenica anticipate additional cash flows to come from research and development tax rebates, with the government providing up to 43.5 per cent in refunds for eligible activities.

There are currently no universally available drugs which protect brain cells following a stroke, a fact Argenica would like to see changed as it discovers what ARG-007 might be capable of in treating the human brain.

Trial status of ARG-007 on neurological issues

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Argenica Therapeutics Limited engages in the research and development of a neuroprotective therapeutic drug in Australia. Its lead product candidate is ARG-007, a neuroprotective peptide candidate use to protect brain cells and reduce cell death during a stroke and other types of neural injuries. Argenica Therapeutics Limited was incorporated in 2019 and is based in Nedlands, Australia.

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