Preclinical safety studies have been successfully completed for Argenica Therapeutics’ (ASX: AGN) stroke drug ARG-007, which paves the way for an ethics submission for a phase one clinical trial.
Argenica’s drug ARG-007 has been developed to reduce brain tissue death after stroke and safety pharmacology preclinical studies have led to “no abnormal symptoms” being observed.
The studies were conducted under the Good Laboratory Practice regulatory framework and assessed the effects on the central nervous system and respiratory system in rats and non-human primates.
These studies aimed to reveal any adverse effects of the drug on the major physiological systems.
Animals received ARG-007 at the efficacious therapeutic range up to the maximum tolerated dose.
Argenica chief executive officer Dr Liz Dallimore said the company is “extremely encouraged” by the safety studies, which showed even at the high doses of ARG-007 no abnormal effects were seen.
“This gives us great confidence as we prepare our ethics submission to gain approval for our upcoming phase one clinical trial,” she added.
Advancing lead candidate ARG-007
Argenica’s focus during the March quarter was completing the preparatory work required for the planned phase one clinical trial including efficacy and today’s announced safety study results.
The only data remaining for the clinical trial is from the final pathology assessment of the toxicology and pharmacokinetic study.
This is expected to be received “shortly”.
The ethics submission is planned to be submitted in the current quarter, with the phase one trial to be undertaken in health human volunteers to assess the safety, tolerability, and pharmacokinetics of single ascending doses of ARG-007.
It is expected 32 people will be enrolled in the trial, with results to provide Argenica with critical data on the safety and tolerability of its lead candidate.
The results will also feed into a phase two trial, where ARG-007 will be administered to stroke patients to determine whether efficacy is seen in a small number of human patients.
As well as its research on stroke victims, Argenica is studying the results of ARG-007 in other types of brain injury, with positive preclinical results revealed in the March quarter on the drug’s impact in cerebral ischaemia.
Cerebral ischaemia refers to blood disruption to the brain and can occur during cardiac arrest and certain cardiac surgeries.