IRX-616a Phase 1 Trial Approved to Test Safety in 24 Volunteers
InhaleRx has secured ethics approval to begin a Phase 1 clinical trial of IRX-616a, a synthetic cannabidiol inhaler aimed at providing fast relief for panic disorder. The fully funded study will assess safety and pharmacokinetics in healthy volunteers.
- HREC approval granted for Phase 1 trial of IRX-616a
- Randomised, double-blind, placebo-controlled single ascending dose study
- Trial to enrol up to 24 healthy volunteers at CMAX, Adelaide
- IRX-616a is a synthetic CBD aerosol delivered via metered-dose inhaler
- Fully funded by $38.5 million agreement with Clendon Biotech Capital
Ethics Approval Marks Key Milestone
InhaleRx Limited has received Human Research Ethics Committee (HREC) approval to initiate the first-in-human Phase 1 clinical trial of its investigational therapy IRX-616a, targeting panic disorder. This approval from the Bellberry HREC clears the way for the company to begin testing the safety and pharmacokinetics of its novel inhaled cannabidiol (CBD) formulation in healthy adult volunteers.
Trial Design and Objectives
The upcoming study will be conducted at the CMAX clinical research facility in Adelaide, South Australia. It is designed as a randomised, double-blind, placebo-controlled, single ascending dose trial enrolling up to 24 participants across three cohorts. Each participant will receive a single inhaled dose of IRX-616a or placebo, allowing researchers to evaluate the drug’s safety profile, tolerability, and how it is processed in the body.
IRX-616a is a synthetic CBD aerosol delivered via a pressurised metered-dose inhaler, a delivery method chosen to enable rapid systemic absorption. Peak plasma levels of CBD are expected within 3 to 10 minutes, positioning IRX-616a as a potential on-demand treatment for acute panic attacks, which can strike suddenly and severely disrupt daily life.
Addressing a Significant Unmet Need
Panic disorder affects many individuals who experience recurrent, disabling panic attacks accompanied by symptoms such as heart palpitations, shaking, and shortness of breath. Current treatment options are limited and often rely on medications like antidepressants, sedatives, or anticonvulsants, which may have undesirable side effects or dependency risks. InhaleRx aims to fill this gap with a rapid-acting inhaled therapy that could offer relief precisely when it is needed most.
Strong Financial Backing and Next Steps
The Phase 1 trial is fully funded through InhaleRx’s clinical development agreement with Clendon Biotech Capital, which provides up to $38.5 million to support the company’s clinical programs through to Phase 3 readiness. With manufacturing processes refined and clinical operations underway, InhaleRx anticipates dosing the first participant in the coming months. Trial registration details will be made publicly available on the Australian New Zealand Clinical Trials Registry.
CEO Darryl Davies highlighted the significance of this milestone, emphasizing the potential for IRX-616a to improve the lives of those living with panic disorder by offering a differentiated, rapid-onset treatment option.
Bottom Line?
As InhaleRx moves into human trials, the market will watch closely for early safety signals and the potential to transform panic disorder treatment.
Questions in the middle?
- How quickly will InhaleRx report initial safety and pharmacokinetic data from the trial?
- What are the prospects for IRX-616a to advance beyond Phase 1 and secure regulatory approval?
- How does IRX-616a compare to existing and emerging treatments for panic disorder in terms of efficacy and safety?
