InhaleRx locks-in ethics approval for phase 1 trial of novel drug IRX211 in treating CRPS
InhaleRx will begin recruiting for its phase 1 trial in using IRX211 to treat CRPS in May.
InhaleRx (ASX: IRX) is a step closer to kicking-off a phase 1 clinical trial of its novel inhaled cannabinoid formulation IRX211 for complex regional pain syndrome (CRPS) after locking in ethics approval.
Alfred Health Human Ethics Committee (HREC) approved the trial, which will investigate the safety and pharmacokinetics of IRX211 at Nucleus Network in Melbourne.
Nucleus Network is a dedicated and experienced trial centre and the study will involve four cohorts of eight participants who will either be given IRX211 or placebo.
Recently appointed contract research organisation Ingenu CRO will be managing the trial, and patient recruitment is scheduled to begin in May, with batch manufacturing due to begin next month.
It aims to demonstrate the drug-device combination’s safety and identify the best dose for a phase II trial.
‘Significant milestone’
InhaleRx chief executive officer Darryl Davies said it was a “significant milestone” to receive approval to begin the phase 1 trial.
IRX211 is a cannabinoid-derived drug dronabinol (THC) and delivered via inhalation in a fixed dose to address CRPS.
Mr Davies said there was a growing trend in patients using cannabinoids to treat a range of pain disorders.
“The unique design of this device-drug combination will allow for patients to have a rapid onset solution to assist with managing breakthrough pain episodes,” he added.
Complex regional pain syndrome
Treating CRPS has a global annual market size exceeding US$7.08 billion per annum.
The disorder is also eligible for an orphan drug designation (ODD) with the US Food and Drug Administration.
Gaining ODD has commercial advantages including exclusivity after securing new drug approval from the FDA.
InhaleRx is advancing IRX211 through the FDA’s regulatory pathway and has booked a pre-investigational new drug meeting for the 30 March.
The meeting will involve discussing the next steps for developing IRX211 for approval in the US.
As part of this, InhaleRx will open an up an investigational new drug application for IRX211 in treating CRPS.