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

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

April 29, 2024 Off By Jack Baker

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

Please note the following valuable information before using this website. 

Independent Research 

Market Open Australia is intended to be used only for educational and informative purposes, and any information on this website should not be taken as investment advice or guidance. It is important to conduct your own research before making any investment decisions, which should be based on your own investment needs and personal circumstances. Any investment decisions based on information contained on this website should be taken in line with independent financial advice from a qualified professional or should be independently researched and verified. 

MO and CI logo redraw Socials Profile reversed

MarketOpen is an online media business connecting companies and investors. Through its flagship media channel the Australian publisher’s experienced journalists cover breaking news and analysis on mining, oil and gas, technology and biotechnology companies listed on the Australian Securities Exchange and other markets. MarketOpen’s video and podcasting channels feature original interviews with Australia’s small-cap corporate leaders, while its Stock Soirée networking events, Watchlist webinars, and online events connect investors and brokers with CEOs and board members. The publisher also offers a suite of agency services to its corporate members, including media, video, podcasting and social media services, along with writing, editing, reviewing and content creation services.

Contact info

Suite 3, 47 Havelock Street
West Perth WA 6005

Stewart Walters
Managing Director
+61 414 644 166

Amanda Ellis
+61 438 003 868

Important links

Follow us