InhaleRx completes first cohort of phase 1 clinical trial for pain management

Melbourne-based healthcare company InhaleRx (ASX: IRX) continues to confirm the potential of its inhaled medication pain medicine systems with the completion of an initial set of trials.

The company has confirmed that phase 1 clinical trials have been successfully undertaken with the first of four cohorts passing through its investigation of the safety and pharmacokinetics of its IRX211 system.

IRX211 is a cannabinoid derived drug dronabinol (THC based) delivered via inhalation in a fixed dose to address the symptoms of break-through or acute pain.

InhaleRx is now testing the drug-device combination product developed to target symptoms associated with breakthrough pain indications, including complex regional pain syndrome and other acute pain indications.

The company’s trial programme is some of the first clinical trials to ever involve inhaled cannabinoid medications for treating pain and anxiety related conditions.

Multi billion dollar market

The chronic pain market has been forecast to expand from US$73.14 billion (A$107 billion) in 2023 to US$142.53 billion (A$210.5 billion) by 2033, growing at a compound annual growth rate (CAGR) of 6.9% over the forecast period.

The company has already achieved important milestones in its push to commercialise its unique product with initial discussions held with the US Food and Drug Administration (FDA) where a pathway has been identified for the obtaining of regulatory approvals.

First cohort campaign

The first cohort of the phase 1 trial featured the dosing of eight participant.

InhaleRx successfully completed the cohort ahead of schedule and has already commenced screening of potential second cohort participants.

The full IRX211 safety and pharmacokinetics trials will involve 4 cohorts of 8 participants for a total of 32 participants who will receive either IRX211, or a placebo in a double-blind, randomised, placebo-controlled, single ascending dose study.

Chief executive officer, Darryl Davies, said the results of the trials, designed to assess single escalating doses of IRX211, will then form a guide for phase 2 and subsequent pivotal trials, as well as a regulatory strategy targeting an eventual submission to the FDA.

“InhaleRx has closed out the first of four cohorts ahead of schedule which is a significant milestone for the company. We are tracking really well with screening our next cohort and we look forward to evaluating the safety, tolerability, and pharmacokinetic profiles of IRX211 to inform our phase 2,” he said.

Mr Davies said InhaleRx believes that inhalation of pharmaceuticals provides unique advantages to patients and physicians due to the large absorption area of the lungs, allowing fast absorption into the bloodstream and fast delivery to target cells.