InhaleRx Faces Governance Hurdles as It Pushes Forward with $38.5M Funded Trials
InhaleRx has locked in a $38.5 million funding deal with Clendon Biotech Capital, enabling expanded Phase 2 trials for its inhaled breakthrough cancer pain and panic disorder treatments. The company also filed a key international patent, positioning itself for a faster path to FDA approval.
- Secured $38.5 million funding agreement with Clendon Biotech Capital
- Phase 2 trial for IRX-211 expanded to 156 patients to enhance efficacy detection
- Filed international PCT patent application for inhaled breakthrough cancer pain treatment
- Appointed Ingenu CRO to oversee clinical trials, pending shareholder approval
- Cash reserves at $194k with disciplined operational spending
Funding Boost and Clinical Progress
InhaleRx Ltd (ASX: IRX) has taken a significant step forward in its development of novel inhaled medicines targeting breakthrough cancer pain (BTcP) and panic disorder (PD). The company announced a $38.5 million funding agreement with Melbourne-based Clendon Biotech Capital, which will fully cover clinical trial costs through to the completion of Phase 2 trials for its two lead drug candidates, IRX-211 and IRX-616a.
This capital injection provides InhaleRx with the financial runway to expand its clinical programs and refine trial designs, moving beyond the constraints of earlier, smaller-scale studies. The funding agreement also includes the issuance of nearly 38.5 million options to Clendon, aligning repayment with the anticipated value uplift upon successful Phase 2 completion.
Expanded Phase 2 Trial Design for IRX-211
With the new funding secured, InhaleRx revisited the Phase 2 trial design for IRX-211, its inhaled treatment for breakthrough cancer pain. Originally planned with a modest sample size of 60 patients, the trial will now enrol 156 patients, a move aimed at increasing the likelihood of detecting a statistically significant efficacy signal. This adjustment could position the Phase 2 data as pivotal, potentially accelerating the regulatory pathway by reducing or eliminating the need for a separate Phase 3 trial.
This strategic shift underscores InhaleRx’s commitment to value creation by potentially shortening development timelines and reducing costs, while enhancing the drug’s competitive positioning in a market currently dominated by opioid-based therapies with safety concerns.
Intellectual Property and Regulatory Strategy
In parallel with clinical advancements, InhaleRx has strengthened its intellectual property portfolio by filing a comprehensive international patent application under the Patent Cooperation Treaty (PCT) for IRX-211. This patent aims to protect the company’s innovative inhalation delivery system and its therapeutic application for BTcP, securing exclusivity in key global markets.
The company is also actively preparing for regulatory submissions, including addressing the FDA’s clinical hold on IRX-616a’s Investigational New Drug application by planning non-clinical toxicology studies. These efforts reflect a broader strategy to leverage rapid and cost-effective regulatory pathways such as the FDA’s 505(b)(2) route.
Operational and Governance Updates
InhaleRx has appointed Ingenu CRO Pty Ltd to oversee the Phase 1 and Phase 2 clinical trials. However, as Ingenu is a related entity through a major shareholder, the company has commissioned an independent expert report to ensure compliance with ASX Listing Rule 10.1. An Extraordinary General Meeting (EGM) is planned for late February or early March to seek shareholder approval for this appointment.
Despite a net cash outflow of $97,000 for the quarter and cash reserves standing at $194,000, the company maintains a disciplined approach to expenditure, focusing on operational efficiency while advancing its clinical programs.
Looking Ahead
InhaleRx’s next steps include formalising the CRO appointment, amending trial protocols to reflect the expanded Phase 2 design, completing manufacturing preparations, and initiating patient dosing. The company’s dual focus on pain and mental health indications, combined with robust funding and intellectual property protection, positions it well to address significant unmet medical needs.
As InhaleRx navigates these critical milestones, the market will be watching closely to see if the expanded Phase 2 trial can deliver the pivotal data needed to fast-track FDA approval and commercialisation.
Bottom Line?
InhaleRx’s strengthened funding and expanded trials set the stage for a potential breakthrough in inhaled therapies, but regulatory and governance hurdles remain key watchpoints.
Questions in the middle?
- Will the independent expert report and EGM approval of Ingenu CRO proceed smoothly without delays?
- Can the expanded Phase 2 trial for IRX-211 deliver statistically significant efficacy data to bypass Phase 3?
- How will InhaleRx manage cash flow given current reserves and planned clinical expenditures?