Australian inhaled drug developer InhaleRx announced that it has received approval from the Bellberry Human Research Ethics Committee for a Phase 1 trial of its IRX-616a MDI, which the company is developing for the treatment of panic disorder. The SAD study is expected to enroll up to 24 healthy adults who will receive either a single dose of IRX-616a or inhaled placebo. According to InhaleRX, initiation of the trial is expected within the next few months.
The company said that Ab-Initio Pharma will manufacture trial supplies of the inhaler. Ab-Initio also manufactured supplies for a Phase 1 trial of InhaleRx’s IRX211 inhaled dronabinol that was initiated in 2023, and earlier this year, InhaleRX announced that Ab-Initio had begun manufacturing for a Phase 2 trial of that MDI for breakthrough cancer pain. The new studies are funded by a $38.5 million funding facility provided by Clendon Biotech Capital.
InhaleRx CEO Darryl Davies commented, “Bellberry HREC approval is a major milestone for InhaleRx and for patients living with the sudden, debilitating episodes characteristic of panic disorder. IRX-616a is designed as a rapid-acting, inhaled option intended to provide relief when it’s needed most. Advancing into Phase 1 brings us one step closer to delivering a differentiated therapy that could meaningfully improve patients’ day-to-day lives.”
Read the InhaleRx announcement
