InhaleRx Faces FDA Clinical Hold and Shareholder Vote Amid $38.5M Funding Deal
InhaleRx has corrected its quarterly report and revealed a $38.5 million funding deal to fast-track clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, aiming for FDA approval.
- Secured $38.5 million funding agreement with Clendon Biotech Capital
- Completed Phase 1 trial report for IRX-211 targeting breakthrough cancer pain
- Filed international patent application under PCT for IRX-211
- Appointed Ingenu CRO for upcoming Phase 1 and Phase 2 clinical trials
- Plans to expand Phase 2 trial size to potentially bypass Phase 3
Funding Boost to Propel Clinical Development
InhaleRx Ltd (ASX: IRX), an Australian biotech innovator specialising in inhaled medicines for pain management and mental health, has updated its quarterly activities report for the December 2024 quarter. The highlight is a $38.5 million funding facility secured from Melbourne-based Clendon Biotech Capital, designed to fully finance the company’s clinical development through to the completion of Phase 2 trials for its two lead drug candidates, IRX-211 and IRX-616a.
This capital injection marks a pivotal moment for InhaleRx, enabling accelerated progress in a competitive and fast-evolving sector. Clendon’s strategic focus on biotech innovation aligns well with InhaleRx’s ambitions to address unmet medical needs in breakthrough cancer pain (BTcP) and panic disorder (PD), both areas lacking safe and effective inhaled treatments.
Clinical Progress and Trial Expansion
The company has officially completed its Phase 1 clinical trial for IRX-211, a novel inhaled cannabinoid treatment for BTcP, with the final Clinical Study Report (CSR) now filed. Encouragingly, InhaleRx has upgraded its Phase 2 trial design, increasing the sample size from 60 to 156 participants. This expanded trial aims to align more closely with pivotal trial standards, potentially allowing the company to bypass a separate Phase 3 study and expedite FDA approval timelines.
For IRX-616a, targeting panic disorder, preparations are underway to commence Phase 1 trials. Manufacturing processes are being refined in collaboration with UK formulation specialists, and procurement of necessary components is on track. The company is also addressing the FDA’s clinical hold on its Investigational New Drug (IND) application by planning non-clinical toxicology studies.
Intellectual Property and Regulatory Strategy
InhaleRx has strengthened its intellectual property position by filing a comprehensive international patent application under the Patent Cooperation Treaty (PCT) for IRX-211. This patent aims to secure global protection for its inhaled breakthrough cancer pain treatment, covering innovations in drug delivery systems and therapeutic applications. Successful patent approval would enhance market exclusivity and support the company’s commercial strategy across key jurisdictions.
The company’s overarching regulatory goal remains obtaining New Drug Approval (NDA) from the US FDA via accelerated pathways such as 505(b)(2), which could reduce development costs and time to market. The appointment of Ingenu CRO, a related-party contract research organisation, to oversee upcoming clinical trials is pending shareholder approval following an independent expert’s fairness report, with an Extraordinary General Meeting expected in early 2025.
Financial Discipline and Operational Updates
Despite the ambitious development plans, InhaleRx maintained a disciplined approach to expenditure, reporting a modest net cash outflow of $97,000 for the quarter. Corporate costs included insurance, legal fees related to intellectual property and funding arrangements, and administrative expenses. Notably, no cash payments were made to directors during the quarter, with remuneration partly settled through share issuance.
Looking ahead, the company is focused on finalising trial site activations, manufacturing clinical batches, and commencing patient dosing for IRX-211’s Phase 2 trial. Concurrently, it is advancing non-clinical toxicology studies to support the lifting of the FDA clinical hold on IRX-616a.
Bottom Line?
With robust funding and strategic patent protection, InhaleRx is poised to accelerate its path toward FDA approval, but clinical outcomes remain the critical next hurdle.
Questions in the middle?
- Will the expanded Phase 2 trial for IRX-211 deliver data robust enough to bypass Phase 3?
- How will the FDA respond to the non-clinical toxicology data for IRX-616a and the lifting of the clinical hold?
- What are the implications of appointing a related-party CRO on shareholder confidence and trial oversight?
