• A preclinical study into Argenica’s lead drug for hypoxic-ischaemic encephalopathy (HIE) shows potential for use as a stand-alone treatment
  • HIE is a type of newborn brain damage which there is no therapeutic drug on the market for treatment
  • Study shows the drug is effective when combined with hypothermia treatment and also in isolated use
  • Argenica is now advancing large animal and juvenile toxicology studies ahead of planned clinical trials in infants

 

A preclinical study has shown that Argenica Therapeutics’ lead drug candidate ARG-007 could be ‘significantly effective’ at reducing total brain injury in a preclinical model of hypoxic-ischaemic encephalopathy (HIE).

HIE is a type of newborn brain damage caused by oxygen deprivation and limited blood flow.

There is currently no therapeutic drug on the market to protect brain cells following cases of HIE. Instead, therapeutic hypothermia (cooling the body to maintain a targeted temperature) is used which can prevent or minimize permanent brain damage in some babies, however, it can result in cardiovascular and respiratory complications.

This preclinical study investigated the reduction in total brain injury following HIE standard of care therapeutic hypothermia and ARG-007 – and the combination of the two – to determine if there was any benefit to combining ARG-007 with standard of care hypothermia.

 

Stand-alone therapy potential

The study showed that 48 hours post-HIE, ARG-007 demonstrated a 46% reduction in total brain injury compared to saline placebo and a 42% reduction in total brain injury compared to therapeutic hypothermia.

 

Argenica Therapeutics ASX AGN
Graph: Total brain injury at 48 hours after HIE and treatment. Source: AGN.

 

The study further demonstrated that ARG-007 sustained a reduction in total brain injury when examined 4 weeks post-HIE, with a single dose of ARG-007 showing a 52% reduction in total brain injury compared to saline placebo and 57% reduction in total brain injury compared to therapeutic hypothermia.

 

Argenica Therapeutics ASX AGN
Graph: Total brain injury at four weeks after HIE and treatment. Source: AGN.

 

Argenica Therapeutics (ASX:AGN) says these findings indicate ARG-007 appears effective regardless of whether hypothermia is used, meaning it could be suitable as a combined neuroprotection therapy for HIE with hypothermia – or as a standalone therapy when hypothermia cannot be used.

 

Aiming to advance to clinical trials

Argenica will now complete larger animal studies to confirm these positive results, as well as juvenile toxicology studies required to advance ARG-007 into clinical trials for infants suffering HIE.

The company will work with Senior Postdoctoral Research Fellow at the Perron Institute and Argenica’s Neonatal Scientific and Regulatory Advisor Dr Adam Edwards to complete larger animal studies in both term and pre-term models of HIE.

This work will be conducted at the University of Aarhus, Denmark, and the University of Western Australia.

Pilot studies for both these preclinical studies are currently in the planning stages, with preliminary data expected in calendar year 2024.

 

 

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.