Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has garnered ethics approval to conduct a clinical trial for its proprietary drug, IHL-42X, aimed at treating obstructive sleep apnoea (OSA).
The tick-off was given by the Bellberry Human Research Ethics Committee (HREC) to proceed with a bioavailability/bioequivalence (BA/BE) trial, which will assess the drug's pharmacokinetics – how the drug moves through the body – and tolerability.
Crucial data for future submissions
The BA/BE clinical trial will involve 116 participants at CMAX Clinical Research in South Australia and will be overseen by Novotech.
The trial will provide crucial data for future marketing submissions of IHL-42X as a treatment for OSA and will run parallel to the commencement of an investigational new drug (IND) application and a pivotal Phase 2/3 clinical trial.
OSA is a widespread sleep disorder that affects some 30 million adults in the United States alone. Despite its prevalence, there are no registered prescription drugs currently available to treat it.
Trial design
The BA/BE trial's design aligns with recommendations from the US Food and Drug Administration (FDA), as part of the necessary research to support a new drug application.
It will take place at CMAX Clinical Research in Adelaide, South Australia, and will be managed by Novotech.
Clinicians hope to evaluate the pharmacokinetics and tolerability of two active pharmaceutical ingredients (APIs) in IHL-42X: dronabinol (THC) and acetazolamide.
The APIs will be compared to their respective FDA reference listed drugs and the trial will also assess the impact of food on their pharmacokinetics.
During the trial, each participant will complete four single-dose treatment periods, receiving IHL-42X, dronabinol and acetazolamide under fasted conditions as well as IHL-42X under fed conditions.
Blood samples will be collected over a 48-hour period and the concentrations of the APIs and their major metabolites will be analysed.
Bridge to historical safety data
By following the FDA's recommendations and receiving specific advice during the pre-IND process, Incannex aims to establish the necessary bridge between IHL-42X and the reference listed drugs, allowing the use of existing safety data through the FDA505(b)2 regulatory pathway.
The results of the BA/BE trial will be a critical component of a future New Drug Application (NDA) for IHL-42X, facilitating the drug's development and potentially reducing costs and timelines. This study will run concurrently with the pivotal Phase 2/3 trial, which will begin once the company opens an IND with the FDA.
Incannex chief scientific officer Dr Mark Bleackley said: “The BA/BE trial is a very important component of the IHL-42X pipeline.
“Being able to bridge to historical safety data on the reference listed drugs for dronabinol and acetazolamide accelerates the development of the drug product and reduces cost and timelines.
“Approval of the study by Bellberry HREC for the BA/BE study allows us to move towards patient recruitment and data collection with CMAX and Novotech.”