Argenica Therapeutics has received a positive safety review from its independent DSMB for the Phase 2 trial of ARG-007 in acute ischaemic stroke patients, with dosing now 86% complete and full recruitment expected by early Q2 2025.
- DSMB recommends continuation of Phase 2 trial with no protocol changes
- 79 of 92 patients dosed, representing 86% trial completion
- One serious adverse event possibly related to study drug but trial deemed safe
- Final DSMB review completed, no further safety reviews planned
- Topline data expected weeks after last patient’s 90-day follow-up
Positive Safety Review Marks Key Milestone
Argenica Therapeutics Limited (ASX: AGN) has announced a significant development in its Phase 2 clinical trial of ARG-007, a novel neuroprotective peptide aimed at reducing brain tissue death following acute ischaemic stroke (AIS). The independent Data Safety Monitoring Board (DSMB) has completed its final safety review after assessing data from 76 patients, representing 83% of the trial cohort. The DSMB concluded that the study is safe to continue without any modifications to the protocol, effectively clearing a critical regulatory and clinical hurdle.
The DSMB’s role is pivotal in ensuring patient safety and trial integrity, comprising independent neurologists and a biostatistician who rigorously evaluate adverse events and study endpoints. Despite one serious adverse event (SAE) deemed possibly related to the study drug, the DSMB found no compelling evidence to halt or alter the trial, underscoring the robustness of ARG-007’s safety profile to date.
Trial Progress and Recruitment Dynamics
With 79 patients dosed out of the planned 92, Argenica’s Phase 2 trial is 86% complete. Eight of the ten activated hospital sites have enrolled patients, demonstrating solid engagement across clinical centers. While recruitment slowed during December and January, the company remains confident that dosing will conclude in early Q2 2025. This timeline aligns with expectations and reflects the typical seasonal variability in patient enrolment for stroke trials.
The trial stratifies patients based on whether they receive tissue plasminogen activator (tPA), a clot-dissolving treatment, allowing Argenica to assess potential interactions between ARG-007 and standard stroke care. This stratification is crucial for understanding ARG-007’s efficacy and safety in real-world clinical settings.
Looking Ahead: Data and Market Implications
Following the completion of dosing, the company’s Clinical Research Organisation partner will provide topline data within weeks after the last patient’s 90-day follow-up. This data release will be a pivotal moment for Argenica, potentially validating ARG-007’s therapeutic promise and influencing its path toward regulatory approval and commercialisation.
Dr Liz Dallimore, Managing Director, highlighted the importance of the DSMB’s role and expressed optimism about the trial’s progress. The positive safety outcome not only reassures investors but also strengthens Argenica’s position in the competitive neurotherapeutics landscape.
As the trial nears completion, market watchers will be keenly observing the forthcoming efficacy data, which could significantly impact Argenica’s valuation and strategic partnerships.
Bottom Line?
With safety confirmed and dosing nearly complete, Argenica stands on the cusp of revealing ARG-007’s true clinical potential.
Questions in the middle?
- Will ARG-007 demonstrate significant efficacy in improving stroke outcomes in the final data?
- How will ARG-007’s interaction with tPA influence its clinical adoption?
- What are the next regulatory and commercial steps following Phase 2 results?