• Argenica’s ethics application to St Vincent’s Hospital Melbourne’s Human Research Ethics Committee has been approved
  • Argenica will undertake a Phase 2 proof of concept clinical trial of ARG-007 in acute ischaemic stroke patients 
  • Biotech awarded a $419k West Australian grant to develop a non-invasive administration route for ARG-007

 

Argenica Therapeutics has the green light to undertake a potentially company making Phase 2 ‘proof of concept’ clinical trial of its lead drug ARG-007 for acute ischaemic stroke (AIS) patients. 

Argenica Therapeutics (ASX: AGN) has announced its ethics application to St Vincent’s Hospital Melbourne’s Human Research Ethics Committee (HREC) has been approved, allowing the biotech company to undertake a Phase 2 proof of concept clinical trial of ARG-007 in acute ischaemic stroke patients.

The Perth-based AGN is developing novel therapeutics to reduce brain tissue death after stroke and other brain injuries.

Its lead drug ARG-007 has been successfully demonstrated to improve outcomes in pre-clinical stroke models, traumatic brain injury and hypoxic ischaemic encephalopathy.

Argenica CEO and managing director Dr Liz Dallimore says proving safety and preliminary efficacy in a human patient population is a pivotal moment for Argenica and the culmination of over a decade of research work to get to this point.

“We are confident we have designed a robust trial that is well structured and considered,” she says.

“Should the trial meet some or all of its endpoints, Argenica and ARG-007 are likely to garner significant commercial interest from large pharmaceutical companies.”

 

Trial sites across 10 Australian hospitals

The HREC approval allows AGN to start establishing trial sites in up to 10 hospitals across Australia.

Up to 92 patients will be dosed in the Phase 2 trial around Australia’s hospitals.

To date, hospitals that have confirmed their participation in the trial include:

  • Sir Charles Gardiner Hospital and Fiona Stanley Hospital in Western Australia;
  • Royal Melbourne Hospital, Monash Medical Centre and Sunshine Hospital in Victoria;
  • Royal Adelaide Hospital in South Australia;
  • John Hunter Hospital and Liverpool Hospital in New South Wales; and
  • Princess Alexandra Hospital in Queensland.

Site governance is due to be completed at each hospital in late Q4 CY 2023.

Patients then presenting to the emergency department at these hospitals with a confirmed AIS caused by an occlusion in a large vessel in the brain and to be treated with endovascular thrombectomy will then be considered for eligibility to participate in Argenica’s trial.

Eligible patients will then immediately receive either a single intravenous (IV) dose of ARG-007 or saline placebo prior to undergoing a thrombectomy procedure.

The trial will be a double-blind study as both patients and staff treating the patients won’t know which treatments are being administered.

AGN says the primary objective of the trial is to evaluate the safety of a single dose of ARG-007 in participants with AIS.

The secondary objective is to characterise the effect of ARG-007 on reducing infarct volume (volume of brain cell death) in participants with AIS.

 

WA grant to further boost ARG-007

Meanwhile, AGN has received a West Australian Government grant of $419k under the Innovation Seed Fund Program to develop a new non-invasive administration route for ARG-007.

The new administration route will complement AGN’s current intravenous administration route formulation for ARG-007.

Given ARG-007’s demonstrated pre-clinical efficacy against chronic as well as acute neurological conditions, AGN sees value in having multiple ways ARG-007 can be administered.

Typically, each administration route will usually require a slightly different  formulation of a drug to maximise its efficacy through that route such as oral, nasal, intramuscular or intravenous.

The benefits of this approach are that the drug delivery better caters to patient preferences as well as different treatment regimes.

The company says patients with chronic conditions such as Alzheimer’s Disease, Parkinson’s Disease and concussion generally prefer drugs that  are easy to administer either by the patient themselves or a health care professional such as a tablet, nasal spray, or EpiPen.

However, for acute conditions – such as AIS, hypoxic ischaemic encephalopathy and severe traumatic brain injury – IV delivery is best because it is imperative that a single dose is delivered to the blood stream quickly.

 

Development of ARG-008

Development of an additional route of administration with a unique formulation will also  enable AGN to create an additional separate and distinct drug product for marketing approval.

Should the new formulation development be successful, the new drug product will be referred to as ARG-008.

Dallimore says the company is grateful for the WA Government’s support towards the project.

“Should Argenica be successful in developing this new administration route of ARG-007, it will allow the company to commercialise a new drug asset for chronic neurological  conditions,” she says.

“Following formulation development for the new route of administration, the project will also assess the efficacy of the new route of administration formulation in a preclinical  animal model of Alzheimer’s Disease to ensure the new route of administration dosing  provides optimal efficacy.”

Dallimore also says should the new route of administration formulation prove both novel and inventive, AGN will seek to lodge a provisional patent to protect the formulation.

 

 

This article was developed in collaboration with Argenica Therapeutics, a Stockhead advertiser at the time of publishing.

 

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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