Argenica (ASX:AGN) stroke drug judged safe for continued efficacy testing

Argenica Therapeutics has grabbed a Data Safety Monitoring Board recommendation that its pivotal second-phase clinical trials of its neuroprotective treatment ARG-007 proceed as planned across 10 Australian hospitals.

Already proven safe for healthy patients in phase 1 testing, the first five stroke patients dosed with ARG-007 in the current ongoing phase 2 study reported no adverse events, a safety now validated by the board’s first review.

The trial’s design to test safety in acute ischaemic stroke patients in Australia and generate preliminary data supporting its ability to reduce brain tissue death after stroke and removal of a clot.

The Royal Melbourne, Princess Alexandra, John Hunter, and Liverpool hospitals are now online, with Royal Adelaide and the Royal Brisbane Women’s and Childrens imminent, with the remaining four facilities set to be on-boarded over the next few months.

“We are grateful to the independent DSMB for completing this important first review of safety data in our phase 2 clinical trial,” Argenica Managing Director Dr Liz Dallimore said.

“We look forward to working with the DSMB throughout the trial as they provide their recommendations.”

Safety is the main hurdle for getting a drug approved, and further reviews will be made up to the 92nd patient that marks the trial’s conclusion.

At that point the data will be unblinded and a proper determination can be made if the drug is both safe and effective at reducing brain injury.

Brain cells only last a few seconds without delivery of needed oxygen and nutrients and can start dying almost immediately.

In layman’s terms, ARG-007 hibernates those cells and prevents them from dying, and with no drug of its kind currently on market, validation of efficacy would position the treatment as a leading candidate in the fight against stroke.

Given the study requires patients in an emergency setting it will likely be a couple of years before a final readout on second phase data, but Argenica plans to submit an Investigational New Drug Application to the US Food and Drug Administration in 2024.

The FDA has already granted Argenica an Orphan Drug Designation and Rare Pediatric Disease Designation for treatment of a rare paediatric condition caught by infants around childbirth.

The designations incentivise companies to develop treatments for rare conditions and provide companies like Argenica critical ongoing FDA interactions, aid in their design of trials, and potentially guarantee a period of US market exclusivity for their products.

Read more on Argenica: Dr Liz Dallimore and the virtue of patients

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