Argenica Therapeutics (ASX: AGN) has revealed positive efficacy results of its stroke drug ARG-007 during pre-clinical trials on animal models with hypoxic-ischaemic encephalopathy (HIE) – brain damage as a result of not receiving oxygen or blood flow.
HIE occurs when oxygen and blood stops flowing to the brain for a period of time and the condition is also referred to as perinatal asphyxia or perinatal hypoxia-ischaemia.
Although HIE can occur in adults, it is most commonly a result of an oxygen-depriving event during birth.
According to Argenica, HIE is one of the most serious birth complications in full term infants. About 2.5 out of 1,000 live births are impacted in developed countries.
The company says reducing brain tissue death in these complications could mean the difference of walking, talking and thinking normally compared to being disabled for life.
Pre-clinical study outcome
Argenica’s pre-clinical study using ARG-007 in HIE was carried out at the Perron Institute for Neurological and Translational Science.
The aim was to explore ARG-007’s neuroprotective properties when administered immediately following hypoxia-ischemia in an animal model equivalent to late pre-term infants (34- 37 weeks gestation).
Results showed that ARG-007 “very significantly” lowered the volume of brain tissue death for HIE models compared to the control group, which received a saline injection.
The only current standard of care is hypothermia, and models treated with ARG-007 also had a “significant reduction” in brain tissue death.
Percentage-wise brain tissue death in ARG-007 treated animals was 50% lower compared to the control group, and almost 40% more than the hypothermia group.
Argenica chief executive officer Dr Liz Dallimore said the pre-clinical data was “extremely encouraging”.
“We now have a number of positive pre-clinical rodent models in HIE confirming the efficacy of ARG-007 to significantly protect brain cells from injury.”
Dr Dallimore said the data showed ARG-007 may have a greater application than just in stroke patients.
“This is a very exciting development for the company, and we look forward to continuing to work with the Perron Institute to progress this application of ARG-007 in further studies.”
Argenica plans to evaluate ARG-007 in more animal efficacy studies. If this research demonstrates similar results, the company will look to undertake clinical trials of ARG-007 in human infants suffering HIE.