Incannex Healthcare (ASX:IHL) has received approval to begin a bioavailability/bioequivalence (BA/BE) clinical trial on IHL-42X.
IHL-42X is the company’s proprietary drug product for treatment of obstructive sleep apnoea (OSA). Incannex says the trial will be conducted at CMAX Clinical Research in Adelaide, South Australia and managed by Novotech.
The clinical trial aims to assess the pharmacokinetics and tolerability of the 2 active pharmaceutical ingredients in IHL-42X, dronabinol (THC) and acetazolamide, compared to the respective FDA reference listed drugs, alongside the effect of food on pharmacokinetics of the 2 APIs.
“Being able to bridge to historic safety data … accelerates the development of the drug product and reduces cost and timelines”
Commenting on receiving ethics approval, 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 historic 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.”
The company reports the design of the BA/BE trial is consistent with U.S Food and Drug Administration recommendations and specific advice received by Incannex in its pre-IND with the FDA regarding the development of IHL-42X for treatment of OSA.
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of obstructive sleep apnoea, traumatic brain injury and concussion, lung inflammation, rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain.