Melbourne-headquartered pain management treatment developer InhaleRx (ASX: IRX) has moved further along the path towards product commercialisation of its IRX211 drug with the maiden dosing of a patient in new trials in Melbourne.
The global chronic pain market was valued at US$69.1 billion (A$103.6 billion) in 2021 and the worldwide chronic pain market size is expected to reach US$140.5 billion (A$210 billion) by 2030, according to a research report published by Spherical Insights & Consulting.
Cannabinoid derived drug
InhaleRx has developed IRX211 from a cannabinoid derived drug dronabinol (THC based) which is able to be uniquely delivered via inhalation in a fixed dose to address the symptoms of acute pain.
The company called upon the services of specialised inhalation expert group based in the UK to develop the pressurised metered dose inhaler (pMDI) while a trial batch was manufactured at Ab Initio Pharma in Sydney.
In the current tests being conducted at the well-regarded Nucleus Network clinical trial centre in Melbourne, the initial patient has now been dosed in the first phase of an international development.
The Alfred Health Human Research Ethics Committee (HREC) approved phase 1 trial is designed to assess the pharmacokinetics (PK), safety and tolerability of single escalating doses of IRX211 in healthy male and female subjects.
Studies to provide critical guidance
InhaleRx chief executive officer Darryl Davies said the company will utilise data from the trial to determine critical guidance for a Phase 2 clinical trial program and subsequent pivotal trials.
The information will also provide support for a regulatory strategy targeting submission to the Food and Drug Administration (FDA) for a New Drug Approval (NDA).
The InhaleRx team has already consulted with the FDA during a pre-IND meeting where the FDA confirmed a range of matters relating to the regulatory pathway for the development and registration of IRX211 in the United States.
“This is a significant milestone for the company and we are on track to complete four cohorts over the coming months,” Mr Davies said.
“There is an increasing amount of data available that shows promising results for the use of THC for pain management. The unique design of this device-drug combination is expected to provide patients with rapid symptom management.”
In assessing the safety, tolerability, and pharmacokinetic profiles of IRX211, four groups of eight participants will be dosed with either IRX211, or a placebo in a double-blind.
Formulation produced in UK
In its path towards development, InhaleRx has already produced an IRX211 formulation in the UK, with a local GMP manufacturer undertaking batch manufacturing.
Formulation development has included a range of experimentation conducted to determine such considerations at the characteristics and plume geometry most suited to delivering the drug via a pMDI device efficiently.
InhaleRx holds an innovation patent and provisional patents for further developments.
