Clinical-stage pharmaceutical company Incannex Healthcare Limited (ASX: IHL) has received approval from Bellberry Human Research Ethics Committee to commence a bioavailability/bioequivalence (‘BA/BE’) clinical trial on IHL-42X, the company’s proprietary drug product for treatment of obstructive sleep apnoea.
The BA/BE clinical trial will assess the pharmacokinetics and tolerability of the two active pharmaceutical ingredients (‘APIs’) in IHL-42X, dronabinol (‘THC’) and acetazolamide, compared to the respective FDA reference listed drugs, as well as the effect of food on pharmacokinetics of the two APIs.
The study will include 116 participants who will each complete four (4) single dose treatment periods, being dosed with IHL-42X, dronabinol and acetazolamide under fasted conditions as well as IHL-42X under fed conditions. Blood samples will be collected over 48 hours and the concentrations of the APIs and their major metabolites in the samples will be analysed.
The clinical trial will be conducted at CMAX Clinical Research in Adelaide, South Australia and managed by Novotech.
The design of the BA/BE trial is consistent with US Food and Drug Administration (‘FDA’) recommendations and specific advice received by Incannex in its pre-IND with the FDA regarding the development of IHL-42X for treatment of OSA.
The results of the BA/BE trial will form a critical component of a future new drug application (‘NDA’), providing the necessary bridge to the reference listed drugs, thereby facilitating the use of historic safety data via the FDA505(b)2 regulatory pathway. Importantly, the BA/BE study will run in parallel to the pivotal Phase 2/3 trial that will commence after the company opens an IND with the FDA.
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,” Chief Scientific Officer Dr Mark Bleackley said.
