Argenica Therapeutics (ASX:AGN), a biotechnology company focused on neuroprotective therapeutics, announced results from key safety studies essential for their IND application to the US Food and Drug Administration.
The studies confirmed that ARG-007, Argenica’s lead neuroprotective peptide, showed no genetic damage in an in vivo micronucleus assay in rats, with a high maximum tolerated dose of 17.5 mg/kg.
The key data bolsters the safety profile of ARG-007 as the company prepares its FDA submission. In a study requested by the FDA, ARG-007 was found to have no impact on the clot-dissolving ability of the standard treatment, tissue plasminogen activator.
This indicates that ARG-007 can be administered alongside tPA, a crucial step for its application in acute ischaemic stroke.
Additionally, the drug demonstrated it does not permanently downregulate neuronal glutamate receptors, supporting its safety and efficacy as a neuroprotective agent.
The result, combined with previously confirmed data, places ARG-007 in a competitive position against other therapeutic candidates.
Liz Dallimore, Managing Director of Argenica, stated, "The results generated from these studies not only support our IND application to the FDA, but also provide further confirmation that ARG-007 has a unique mechanism of action and pharmacological profile which lends itself to being an ideal therapy in acute ischaemic stroke."
Argenica plans to submit its IND application by the end of 2024 and is fully funded to complete its ongoing Phase 2 clinical trial in AIS patients.
The trial is progressing well with no reported safety issues.