A neuroprotective drug being developed to reduce brain tissue death after stroke and other brain injuries has successfully passed a critical milestone.
WA based biotech company Argenica Therapeutics has announced results of the Phase 1 Clinical Trial Report confirming that the drug ARG-007 is well tolerated and has a favourable pharmacokinetics profile in healthy volunteers.
The report of the trial was provided by clinical research organisation Linear Clinical Research.
The action of the drug is to protect brain cells and reduce cell death following a stroke and other types of neural injury to minimise the neurological impact of these conditions and improve patient recovery.
It is intended for ARG-007 to be administered by early responders, particularly for rural and remote locations.
The Phase 1 Clinical Trial Report said all doses of ARG-007 administered to healthy participants were safe and well tolerated with no dose-related findings noted for any of the evaluated safety parameters.
ARG-007 was also shown to have an extended half-life (time in which the drug remains in the body) suggesting prolonged efficacy, a critical requirement for neuroprotective drugs for indications such as ischaemic stroke and hypoxic-ischaemic encephalopathy (HIE), a type of newborn brain damage caused by a lack of oxygenated blood flow, usually during or near the time of birth.
The Phase 1 Clinical Trial Report is a critical component of Argenica’s ethics submission for initiating a Phase 2 trial in ischaemic stroke patients.
It is anticipated that the ethics submission will be lodged in the third quarter of 2023.