With FDA Orphan Drug and Rare Pediatric Disease designations, Argenica Therapeutics (ASX:AGN) strengthens its path forward for ARG-006, a promising treatment for neonatal brain injuries in hypoxic-ischaemic encephalopathy (HIE).
ARG-007’s unique mechanism of action and proven safety profile position it as a strong contender in the acute ischaemic stroke treatment landscape.
Argenica Therapeutics is advancing its novel neuroprotective drug ARG-007 through a promising Phase 2 trial, with no adverse events reported and potential applications in multiple neurological conditions.
Pivotal trials which could position an Australian therapeutic as a leading candidate in the fight against stroke continue on pace.
More preclinical data showing efficacy on an animal model has Argenica further on the path toward clinical trials for traumatic brain injury.
ARG-007 trials will continue unmodified across ten Australian hospitals after no adverse events in the first five patients.
Five patients have now safely been dosed and Argenica marks another milestone in pivotal second phase trials in the battle against stroke.
Argenica’s Liz Dallimore on clinical trials, cerebral tribulations, and dosing its first patient in the battle against stroke.
A first dosing marks the official beginning of Phase 2 clinical trials to prove ARG-007’s efficacy in treating victims of acute ischaemic stroke.
A Pediatric Disease Designation for Argenica’s therapeutic opens the post-clinical way for a priority review and path to market.