Argencia’s positive Phase 1 trial results give hope to reducing brain tissue death after stroke and other types of brain injury.  

Biotechnology player Argenica Therapeutics (ASX:AGN) has announced positive results of its Phase 1 trial confirming ARG-007 is safe, well tolerated and has a favourable pharmacokinetics profile.

AGN is developing novel therapeutics to reduce brain tissue death after stroke and other types of brain injury, along with neurodegenerative diseases to improve patient outcomes.

Its lead neuroprotective peptide candidate, ARG-007, has been successfully demonstrated to improve outcomes in pre-clinical stroke models, traumatic brain injury (TBI) and hypoxic ischaemic encephalopathy (HIE).

HIE is when not enough oxygen or blood goes to a baby’s brain causing brain injury.  ARG-007 has been shown to significantly reduce brain injury caused by both ischemia (reduced blood flow) and vasogenic oedema (brain swelling) in a full-term-equivalent animal model of HIE.

The latest Phase 1 clinical trial in healthy human volunteers assessed the safety and tolerability of a single dose of ARG-007 with the final report provided by clinical research organisation Linear Clinical.

Confidence to proceed to Phase 2

The result shows the pharmacokinetic profile seen in humans aligns with the pharmacokinetic profile seen at the effective doses tested in animals, giving AGN confidence in its dose selection for the Phase 2 trial.

Furthermore, the rapid uptake of ARG-007 indicates the fast-acting nature of the drug, a critical requirement for neuroprotective drugs delivered in acute indications such as ischaemic stroke and hypoxic ischaemic encephalopathy (HIE).

ARG-007 is also shown to have an extended half-life (time in which the drug remains in the  body) suggesting prolonged  efficacy  at  the  effect  site,  also  important  for  acute  conditions such as ischaemic stroke and HIE.

The final 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 Q3 CY2023.

AGN managing director Dr Liz Dallimore said receipt of the final Phase 1 clinical trial report is a huge milestone for the company.

“We now have quality assured data showing ARG-007 is safe and well tolerated in humans, and is fast acting, reaching its maximum concentration in the blood at 10 minutes but with a relatively long half-life to exert its action for longer.

“With 1.9 million brain cells dying every minute after stroke, time to maximum drug concentration is critical.”

AGN is now working towards finalising an application to a Human Research Ethics Committee requesting approval to commence a Phase 2 clinical trial in acute ischaemic stroke patients. It is anticipated that this ethics submission will be made in Q3 CY23.

 

 

 

This article was developed in collaboration with Argenica Therapeutics, a Stockhead advertiser at the time of publishing.

 

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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