Incannex receives ethics approval for BA/BE clinical trial on IHL-42X

Incannex Healthcare announced that Incannex has received approval from Bellberry Human Research Ethics Committee to commence a bioavailability/bioequivalence 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 in IHL-42X, dronabinol 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 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 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, 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.