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Incannex Healthcare June 2023 Quarterly Activities Report and Appendix 4C Cash Flow Statement
MELBOURNE, Australia, July 28, 2023 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ:
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"MELBOURNE, Australia, July 28, 2023 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL), (‘Incannex’ or the ‘Company’), is pleased to provide its quarterly activities report and appendix 4C for the period ended 30 June 2023. Incannex is undertaking a multitude of U.S. Food and Drug Administration (‘FDA’) research and development (‘R&D’) programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by health professionals. Incannex Receives Ethics Approval for Bioequivalence/Bioavailability Clinical Trial for IHL-42X During the quarter, Incannex received approval from the Bellberry human research ethics committee (‘HREC’) to commence a bioavailability/bioequivalence (‘BA/BE’) clinical trial to assess the pharmacokinetics and tolerability of IHL-42X, which is the Company’s proprietary drug for treatment of Obstructive Sleep Apnoea (‘OSA’). 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. 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. Incann...