New Podcast! Argenica Therapeutics Trials New Stroke Therapy

23 April 2024

In a recent episode of the MTPConnect Podcast, we spoke to Perth-based biotech company Argenica Therapeutics about its pioneering novel stroke therapy and advancing a Phase 2 clinical trial.

A stroke occurs every 19 minutes in Australia. In 2019, it was reported that 13 million people globally reported a stroke for the first time with the economic cost reaching $183 billion by 2030.

Argenica Therapeutics is on a mission to address this global health challenge. Based on research from the University of Western Australia and the Perron Institute for Neurological and Translational Science, it is on a path to commercialise ARG-007, a pioneering novel neuroprotective peptide therapy designed to reduce brain damage after stroke and other severe brain injuries.

Argenica’s CEO Dr Liz Dallimore explained to podcast hosts Caroline Duell and Dr Tracey Wilkinson, how the therapy targets ischaemic strokes caused by a clot in a blood vessel, which effects around 85 per cent of patients. The current procedure for patients with a clot in a large vessel in the brain is to have an endovascular thrombectomy where a shunt is put into the groin and a stent retriever aspirates out or sucks out the clot in the large vessel. While it is a very effective procedure, it needs to be performed by specialist neuro interventional radiologist in a hospital setting under guided imaging.

“The risk to the patient is if they arrive at the hospital and have to wait for scanning, there will be a proliferation or cascading of cell death. There's a saying in stroke that ‘time is brain’. So, for every minute that a clot stays in the brain, we get around 1.9 million brain cells dying.

“The idea with a neuro protective drug like ARG-007, is it can stop that brain cell death. And really buy that patient time to get the treatment that they need to remove the clot,” Dallimore said.

In March 2024, Argenica Therapeutics announced commencement of the Phase 2 clinical trial for the therapy with stroke patients presenting to emergency departments across ten Australian hospitals. Dallimore explained that the first ischaemic stroke patient has been dosed, with the primary endpoint being to show that the drug is safe in ischaemic stroke patients and working to protect brain injury.

Dr Dallimore said the company chose Australia to conduct its clinical trials because ethics approval could be fast-tracked. Also, Australian hospitals treating stroke and neurological conditions are world class with Australia’s standard of care equal to the US at about a fifth of the cost.

“It's just such a good story – an Australian-developed drug, an Australian company, Australian trials. We will continue to do as much as we can in Australia because the clinical trial and the research landscape here really are absolutely phenomenal having worked a bit across Europe and the US. It’s great to have the capabilities here,” she said.

In November 2023, the United States Food and Drug Administration (FDA) granted its neuroprotective drug ARG-007 with the Orphan Drug Designation for the treatment of Hypoxic Ischaemic Encephalopathy (HIE). More recently, it was granted Rare Pediatric Disease Designation (RPDD) for the treatment of HIE in newborn term infants, further validating the company’s R&D activities.

In mid-April, the company successfully completed a $12.0M placement supported by large existing shareholders, new institutional investors, family offices, and sophisticated high-net-worth investors. Argenica is now fully funded to complete its Phase 2 trial of ARG-007 in ischaemic stroke patients, as well as progress studies in its other neurological indications such as Traumatic Brain Injury, Alzheimer’s disease and Hypoxic Ischemic Encephalopathy.

To hear more from Dr Dallimore about Argenica Therapeutics activities, listen to the full podcast interview here.