Argenica Therapeutics Limited (ASX: AGN) has received positive efficacy results from a preclinical study of ARG-007 in a late pre-term animal model of hypoxicischaemic encephalopathy (HIE); also referred to as perinatal asphyxia or perinatal hypoxiaischaemia.
Argenica is a biotechnology company developing novel therapeutics to reduce brain tissue death after stroke and other types of brain injury.
Argenica’s CEO, Dr Liz Dallimore, said HIE is a type of brain damage that occurs when the brain does not receive enough oxygen or blood flow for a period of time. Although adults can experience HIE, it most commonly occurs as the result of an oxygen-depriving event during or around the time of birth.
HIE is one of the most serious birth complications affecting full term infants. It affects around 2.5 per 1000 live births in developed countries.
The study, undertaken at the Perron Institute for Neurological and Translational Science (Perron Institute), aimed to explore the neuroprotective properties of ARG-007 when administered immediately following hypoxia-ischaemia in an animal model equivalent to late pre-term infants (34 to 37 weeks gestation).
The results showed that ARG-007 very significantly reduced the volume of brain tissue death (infarct volume) for HIE compared to the control group which received a saline injection instead of ARG-007.
The study also assessed the comparative neuroprotection of ARG-007 versus hypothermia, which is currently the only treatment available which improves neurological outcomes for late pre-term and term infants with HIE (current standard of care).
Compared with hypothermia, ARG-007 also showed a significant reduction in the infarct volume. The percentage reduction in infarct volume for ARG-007 treated animals was 50% (300 nmol/kg dose of ARG-007) compared to the control group, and close to 40% compared to the hypothermia treated group (300 nmol/kg dose of ARG-007.
This preclinical data further confirms the neuroprotective capability of ARG-007 in infant HIE, which is extremely encouraging,” Dr Dallimore said.
“We now have a number of positive preclinical rodent models in HIE confirming the efficacy of ARG007 to significantly protect brain cells from injury. This data is important because it shows that ARG-007 may have a greater application moving forward than just in the area of stoke 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.”
Next Steps
Following this positive data, Argenica will now look to progress further animal efficacy studies of ARG-007 in term animal models of HIE.
Should these studies also show neuroprotective efficacy of ARG-007, Argenica will look to establish a clinical programme of development for ARG007 in HIE in human infants.