InhaleRx Boosts IRX-211 Trial Size to 156 with Rapid Ethics Approval
InhaleRx has secured swift Human Research Ethics Committee approval for its redesigned IRX-211 Phase 2 trial, expanding participant numbers and potentially bypassing Phase 3 to speed market entry.
- Rapid HREC approval granted without queries
- Trial participant target increased from 60 to 156
- Potential to eliminate Phase 3 trial phase
- Manufacturing secured with first Clendon Capital drawdown
- Patient dosing expected to start in Q3 2025
Swift Regulatory Green Light
InhaleRx Limited (ASX, IRX) has achieved a significant milestone with the rapid approval of its redesigned IRX-211 Phase 2 clinical trial by the Human Research Ethics Committee (HREC). Notably, this approval came without any requests for additional information, underscoring the robustness and quality of the revised trial protocol. This expedited regulatory nod positions InhaleRx to advance its clinical program with minimal delay.
Expanded Trial Design and Statistical Power
The redesigned trial notably expands its scope, increasing the sample size from 60 to 156 participants, with a target of 78 completing the study compared to the previous 24. This substantial increase aims to enhance the statistical significance of the trial data, potentially providing more definitive evidence of IRX-211’s efficacy and safety. Such a design adjustment reflects a strategic move to strengthen the clinical dataset and improve the drug’s regulatory prospects.
Accelerated Path to Market
One of the most compelling aspects of this announcement is the possibility that the expanded Phase 2 trial could allow InhaleRx to bypass a traditional Phase 3 trial. If regulators accept the enhanced data package, this could dramatically shorten the development timeline, bringing IRX-211 to patients faster and reducing costs. This potential regulatory efficiency is a critical value driver for the company and its shareholders.
Manufacturing and Next Steps
InhaleRx has already secured manufacturing capacity with Ab Initio Pharma, a GMP-accredited partner in Sydney, through the first drawdown of $247,500 from its Clendon Capital facility. This step ensures that batch manufacturing and stability testing are underway, setting the stage for patient dosing to commence in the third quarter of 2025. CEO Darryl Davies highlighted the company’s confidence in the revised clinical program and its readiness to progress IRX-211 through this critical phase.
Strategic Implications
IRX-211 targets significant unmet medical needs in breakthrough cancer pain and panic disorder, areas with limited safe and effective treatments. The accelerated trial and potential regulatory shortcuts could position InhaleRx as a nimble player in these therapeutic sectors. Investors will be watching closely to see how the company navigates upcoming clinical milestones and regulatory interactions.
Bottom Line?
InhaleRx’s rapid HREC approval and trial expansion set the stage for a potentially faster, more cost-effective route to market for IRX-211.
Questions in the middle?
- Will regulatory authorities accept the expanded Phase 2 data in lieu of a Phase 3 trial?
- How will the increased trial size impact overall development costs and timelines?
- What are the key milestones and data readouts investors should anticipate next?
