Australian healthcare company InhaleRx (ASX: IRX) has submitted an ethics application for a Phase 2a clinical trial investigating the safety and efficacy of lead candidate IRX616a in patients with panic disorder.
The application was submitted to Bellberry Human Research Ethics Committee last week and is based on a proof-of-concept trial to be carried out at the dedicated Vitalis clinical trial centre in Melbourne.
The trial will consist of three treatment arms with 36 patients each, for a total of 108 participants.
InhaleRx chief executive officer Darryl Davies said the Phase 2a data would be critical in informing the design of a subsequent pivotal Phase 3 trial.
“We are confident the trial design for IRX616a will be well received by Bellberry and we are looking forward to further trials to measure the effect that this drug-device combination product will have on participants suffering with panic disorder,” he said.
Data from all trials will be used for registering IRX616a with the US Food and Drug Administration (FDA) via a new drug approval (NDA) application.
Mr Davies said the InhaleRx board had been “very encouraged” by feedback received from a pre-investigational new drug (PIND) meeting with the FDA earlier this month.
IRX616a is a drug-device product consisting of synthetic cannabidiol (CBD) and delivered via fixed-dose inhalation to treat patients with diagnosed panic disorder.
The drug-device combination utilises a pressurised metered dose inhaler (pMDI) which has been formulated under Good Manufacturing Practices (GMP) and stability studies are ongoing.
The drug’s active pharmaceutical ingredients (API) have been imported and manufacturing is expected to commence once ethics approval has been granted.
The start of patient recruitment for the trial will be subject to further planned capital raisings.
Recurrent and disabling attacks
Panic disorder refers to the experience of recurrent and disabling panic attacks which can last up to a few minutes and are accompanied by physical symptoms such as heart palpitations, shaking, shortness of breath and dizziness.
There are currently no effective treatments and sufferers are forced to rely on atypical antidepressants, sedatives or anti-convulsants.
The global anxiety disorder treatment market is projected to reach $14 billion by 2030 at a 2.9% compound annual growth rate.