Biotechnology company Argenica Therapeutics Limited (ASX: AGN) has completed the preliminary preclinical toxicology studiesin both rat and non-human primates(NHPs), and preliminary in vitro genotoxicity studies for its novel therapeutics being developed to reduce brain tissue death after stroke.
These studies, carried out under non-Good Laboratory Practice (non-GLP) conditions, are necessary to identify the suitable dose ranges for further testing under the principles of Good Laboratory Practice (GLP) and provide an indication of the no observed adverse effect level (NOAEL) of ARG-007 required for determining the doses for the Phase 1 clinical trial.
Through these studies, Argenica has successfully identified the safe dosing range, which importantly exceeds the efficacious dose range, allowing the company to confidently progress to the full GLP studies required to initiate its Phase 1 clinical trial.
CEO, Dr Liz Dallimore, also confirmed that ARG-007 administered at doses that are not bactericidal, does not appear to cause mutations in the DNA of the test organism – the “mutagenic potential”.
“The results of these non-GLP studies have provided us with great confidence as we finalise our GLP preclinical studies. Identifying the dose ranges for our critical toxicity studies and estimating ARG-007’s no observed adverse effect level, which is importantly above our efficacious dose, is a vital step in achieving Human Research Ethics Committee approval and commencing our Phase 1 clinical trial.”
Next Steps
Given Argenica has completed the non-GLP studies necessary for the progression of the required GLP studies, the Company has now begun the final GLP studies for pharmacokinetics (PK) and toxicity, and safety studies will follow shortly after.
These GLP studies will confirm the safety and tolerability of single doses of ARG-007 prior to commencement of the Phase 1 clinical trial. The results of these pre-clinical studies will be reported throughout Q1 CY22.
The GLP genotoxicity studies are nearing completion and the results will be reported within Q1 2022. The data collected in both the non-GLP and GLP studies will be available for the Human Research Ethics Committee (HREC) review for approval of the Phase 1 clinical trial.
Engagement with the HREC and submissions of data packages will commence in Q1 2022.
