Argenica Therapeutics (ASX:AGN) stroke trial nears completion with DSMB green light
January 30, 2025Perth-based Argenica Therapeutics (ASX:AGN) is closing in on a major clinical milestone as its Phase 2 trial of ARG-007 for acute ischaemic stroke (AIS) patients nears completion, with the independent Data Safety Monitoring Board (DSMB) granting an unqualified safety endorsement that allows the trial to proceed without modification.
More than just a procedural step, this approval is a significant win in a sector where trial setbacks can swiftly erode valuations.
Of the 76 patients reviewed, the DSMB found no red flags, clearing the path for Argenica to complete final patient dosing in the coming months.
A Critical Moment for Stroke Treatment
Stroke remains a leading cause of disability worldwide, with treatment options largely restricted to clot-busting drugs like tissue plasminogen activator (tPA) or mechanical clot retrieval, both of which have narrow treatment windows and are not universally effective.
Argenica’s candidate, ARG-007, takes a different approach by focusing on protecting brain tissue from the damage inflicted by stroke itself rather than targeting the clot directly.
If successful, it has the potential to reshape stroke care by extending the treatment window and significantly improving patient recovery outcomes.
Argenica Therapeutics Managing Director Dr Liz Dallimore called the latest DSMB review a “significant milestone” as the company edges closer to completing the trial. “DSMBs play an integral role in ensuring the safety of trial participants, and without their professionalism and expertise, our trial could not have progressed,” she said
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What Comes Next?
With 79 of the planned 92 patients dosed, recruitment is 86% complete, and the final few participants are expected to be enrolled by early Q2 2025.
While recruitment slowed over the December–January holiday period—an expected seasonal lull—the overall trajectory remains positive.
One key aspect of the trial is its stratification of patients who receive tPA and those who don’t.
This design will help determine whether ARG-007 enhances the effectiveness of clot-busting drugs or works independently.
Argenica’s clinical research partner has confirmed that top-line results will be available within weeks of the final 90-day follow-up, meaning investors won’t be waiting long for the next update.
The Bigger Picture
This is more than just another biotech milestone; the stroke treatment landscape has remained largely unchanged for decades, and the prospect of a neuroprotective therapy that can be administered alongside existing treatments—or even stand alone—would represent a major breakthrough.
The real test now lies in whether ARG-007 can demonstrate clinical efficacy in its final readout, and if the results align with the promise shown in preclinical studies, Argenica won’t just have a successful trial on its hands—it could be on the verge of a paradigm shift in stroke care.
With the final patient dosing approaching and the subsequent data readout anticipated, all eyes will be on Argenica, and if it delivers, the market will be quick to take notice.
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