Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL) an Australian pharmaceutical firm, has received approval to kick off a critical clinical trial on IHL-42X, its proprietary treatment for obstructive sleep apnea (OSA).
The green light from the Bellberry Human Research Ethics Committee was announced Thursday and set the stage for an in-depth study of the drug’s behaviour and tolerability in the human body.
The study is set to include 116 participants, with each completing four single-dose treatment periods, being administered with IHL-42X, dronabinol and acetazolamide under fasted conditions and IHL-42X under fed conditions.
Blood samples will be taken over 48 hours and analyzed for the concentrations of the APIs and their major metabolites. The clinical trial will be carried out at CMAX Clinical Research in Adelaide, South Australia, with Novotech overseeing the process.
The trial data will be vital for any future applications to introduce new drugs, as it helps to compare IHL-42X to existing, approved drugs.
This comparison facilitates the use of previous safety data, saving both time and money in the process. Additionally, this trial will take place simultaneously with a key Phase 2/3 trial, set to start as soon as the company submits an Investigational New Drug (IND) application to the FDA.
OSA is a sleep disorder affecting nearly 30 million adults in the United States alone, and currently, there are no approved prescription drugs available for its treatment. Hence, if successful, IHL-42X could mark a significant step forward in managing this widespread condition.
“The BA/BE trial is a very important component of the IHL-42X pipeline. Being able to bridge to historic safety data on the reference listed drugs for dronabinol and acetazolamide accelerates the development of the drug product and reduces cost and timelines,” CSO Mark Bleackley said in a statement.
“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.”