Argenica Therapeutics launches Phase 2 trials into novel stroke therapy drug

06 March 2024

Perth-based Argenica Therapeutics Limited (ASX: AGN) is developing pioneering novel neuroprotective therapies designed to reduce brain damage after stroke and other severe brain injuries. 

With strokes occurring approximately every 19 minutes in Australia and 13 million global cases reported in 2019, Argenica is actively addressing a critical global health challenge, with the economic cost to treat stroke victims estimated to reach $183 billion by 2030.

Last week the company announced initiation of a Phase 2 clinical trial for its novel drug, ARG-007, with the aim of reducing brain tissue damage post-stroke. The treatment is engineered to improve patient outcomes by protecting the brain tissue from dying until blood flow can be restored. The drug has the potential to reduce further brain injury and long-term disability.

The Phase 2 trial involves 92 stroke patients across ten Australian hospitals, including Sir Charles Gairdner Hospital and Fiona Stanley Hospital in Perth. 

With manufacturing completed, clinical trial sites are gearing up for patient dosing scheduled for March 2024. The primary endpoint of the trial is to assess the safety of ARG-007 in acute ischaemic stroke (AIS) patients, representing a critical step in advancing to a Phase 3 trial.

Notably, Argenica envisions broader applications for ARG-007 beyond stroke treatment, with researchers exploring its potential efficacy in halting or slowing Alzheimer's disease. 

Government funding underscores the significance of this research, with the Western Australian government contributing a $419,000 grant from the Future Health Research and Innovation Seed Fund Program.

In a recent media statement, WA Minister for Innovation & the Digital Economy; Science; Medical Research Hon Stephen Dawson commented on the company's milestone, stating, "It's great to see companies like Perth-based Argenica Therapeutics progress through to clinical trials with a drug that has the potential to revolutionise how a stroke is treated.

“Global pharmaceutical companies will be watching this trial very closely as this drug could be effective against other illnesses, such as Alzheimer's and Parkinson's disease.”

WA Life Sciences Innovation Hub’s Stakeholder Engagement Director Dr Tracey Wilkinson believes this milestone is indicative of the wider state of the sector.

"It’s fantastic to see a WA company like Argenica reach this impressive milestone, and even more so that they can conduct their trial on home soil and benefit Australian patients.

“It is indicative of the Australian sector’s increasing capability to keep work, opportunities, and trials onshore and further enhance our sector’s capacity in the future.

“The WA Life Sciences Innovation Hub looks forward to continuing to support Argenica’s work and other biotech companies on their pathway to develop novel medical products,” said Dr Wilkinson.

Argenica Therapeutics was incorporated in 2019 to undertake the development and commercialisation of a novel drug based on the pioneering work of Professor Bruno Meloni and Clinical Professor Neville Knuckey at the University of Western Australia (UWA) and the Perron Institute for Neurological and Translational Science (Perron Institute).