Participant dosing in the Phase 1 clinical trial to test the safety of ARG-007 has been completed, with healthy participants showing no serious adverse events.
This neuroprotective peptide drug developed by researchers at the Perron Institute and The University of Western Australia is a novel therapeutic aimed at reducing brain tissue death after ischaemic stroke.
It is being commercialised by WA biotechnology company Argenica Therapeutics.
Results of the Phase 1 trial conducted at Linear Clinical Research within the QEII Medical Centre indicate the drug is safe and well tolerated in healthy participants.
Argenica’s latest ASX announcement said the fourth dosed cohort, which received the highest dose of ARG-007, showed no adverse events related to the drug. Throughout the trial, all four doses were well tolerated.
Perron Institute Head of Stroke Laboratory Research and Argenica Chief Scientific Officer Professor Bruno Meloni (pictured) said: “Additional clinical studies will test the safety and efficacy of ARG-007 in stroke patients, but the outcomes of dosing in healthy volunteers are an important achievement and we’re incredibly proud.”
Argenica CEO and Managing Director, Dr Liz Dallimore described the completion of dosing in the Phase 1 clinical trial as a pivotal milestone, showing that ARG-007 is safe and well tolerated in healthy humans.
“This paves the way for testing ARG-007 in stroke patients and others with neurological conditions where a single dose has shown efficacy in preclinical studies,” she said.
“This includes conditions such as cardiac arrest, severe traumatic brain injury and hypoxic ischaemic encephalopathy, a brain injury that occurs when a baby’s brain does not receive enough oxygen immediately before or during delivery.
“Argenica is planning for a Phase 2 trial to assess the safety, tolerability, and efficacy of ARG-007 in ischaemic stroke patients, and Phase 1 trial data will be finalised and submitted as part of the ethics approval process.”
The Phase 2 trial conducted at Australian hospitals nationally will test the primary outcomes of safety and tolerability in patients who have suffered an acute ischaemic stroke caused by a clot in a large vessel in the brain.
To select the organisation to undertake this next trial, Argenica is in discussions with global clinical research organisations experienced in conducting Phase 2 trials in acute emergency settings in Australia.