Every 19 minutes, an Australian suffers a stroke, and every hour that the treatment is delayed, the brain ages up to four years. That paints a rather bleak picture, but that is exactly what biotech company Argenica Therapeutics Limited (ASX: AGN) is addressing as it receives ethics approval from Bellberry’s Human Research Ethics Committee (HREC) to commence a Phase 1 healthy participant study of its brain-protection solution ARG-007. 

Argenica’s ARG-007 is a neuroprotective peptide that protects the brain following a stroke or injury to the central nervous system, like a traumatic blow to the head. The dose reduces neural cell death and damage, which subsequently reduces patient recovery time. As per the Company’s report, ARG-007’s protective effect remained significant (70%), showing a significant reduction in brain tissue death for at least 28 days post stroke following a single IV injection.

Argenica CEO and Managing Director, Dr Liz Dallimore commented on the trials, “We are delighted to receive ethics approval for our first-in-human study of ARG-007. This is a pivotal moment for Argenica, as we take ground-breaking research from the Perron Institute and the University of Western Australia into the clinic.”

The trial will be run by Linear Clinical Research at its dedicated clinical trial facility in Perth, Western Australia. The facility will recruit healthy volunteers, and their dosing will begin in October, 2022. In the Phase 1 trial, up to 32 subjects will be dosed. They will be randomly assigned to get either ARG-007 or a placebo (at a ratio of 3:1 respectively) administered as a single IV dose on day 1. 

Argenica will investigate four cohorts in this study, with each featuring eight participants. The amount of the dose of ARG-007 or placebo will vary depending on the cohort, going from the lowest dose to the highest with each subsequent cohort. Each cohort will include two sentinel subjects (1 assigned to ARG-007 and 1 assigned to placebo).

The two sentinel subjects will be dosed 24 hours before the other subjects, and they will be monitored. This will help determine the safety level of the dose. Only if it is found to be safe and well-tolerated after 24 hours by the investigator will the remaining subjects in the cohort receive their doses.

After dosing, researchers will be studying different aspects, such as safety, immune response, tolerability and pharmacokinetics, i.e. what the drug does to the body at large. 

Argenica is not alone in its pursuit of a novel medicinal miracle to mitigate the consequences of a stroke. Its nearest competitor (NA-1) has shown to reduce brain tissue death by 44%. However, Argenica claims to have one-upped them by showing a 66% reduction in brain tissue death 24 hours after a stroke.

If the clinical trials go well, ARG-007 will be well on its way to becoming a go-to solution for medical practitioners who work in-field.