Argenica Therapeutics completes pre-clinical toxicology studies of stroke drug
Argenica Therapeutics has identified the safe dosing range of its stroke treatment ARG-007, an important precursor to commencing a phase one clinical trial.
Biotech company Argenica Therapeutics (ASX: AGN) has announced the completion of preliminary pre-clinical toxicology studies and genotoxicity studies of its lead stroke treatment drug ARG-007.
The company, which aims to develop novel therapeutics to reduce brain tissue death after stroke, completed the toxicology studies in both rat and non-human primates while the genotoxicity studies were in vitro, and both studies were carried out under non-Good Laboratory Practice conditions.
Argenica said the studies were 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 of ARG-007 required for determining the doses for the phase one clinical trial.
Through these studies, the company has identified the safe dosing range, which exceeds the efficacious dose range, and can now confidently progress to the full GLP studies required to initiate its phase one clinical trial.
Argenica also confirmed that ARG-007 administered at doses that are ‘not bactericidal’ (capable of killing bacteria) does not appear to cause mutations in the DNA of the test organism.
Argenica chief executive officer Dr Liz Dallimore said the results of the non-GLP studies provide the company with “great confidence” as the GLP preclinical studies are finalised.
“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 one clinical trial,” Dr Dallimore said.
Next steps
Argenica has now begun the final GLP studies for pharmacokinetics and toxicity with safety studies to follow shortly.
The GLP studies will confirm the safety and tolerability of single doses of ARG-007 with results to be reported throughout this current first quarter of 2022.
The GLP genotoxicity studies are also nearing completion and results will be reported this quarter, the company said.
Data collected from both the non-GLP and GLP studies are expected to be submitted for the Human Research Ethics Committee review this quarter for approval of the phase one clinical trial.