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Incannex Development Update for IHL-42X for Obstructive Sleep Apnoea (‘OSA’)
Highlights: Incannex has engaged CMAX Clinical Research and Novotech CRO to undertake a bioavailability/bioequivalence (‘BA/BE’) study to assess the
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Highlights: Incannex has engaged CMAX Clinical Research and Novotech CRO to undertake a bioavailability/bioequivalence (‘BA/BE’) study to assess the pharmacokinetics and tolerability of IHL-42X in 116 participantsIncannex is well progressed in drafting an Investigational New Drug (‘IND’) Application for submission to the US Food and Drug Administration (‘FDA’) in Q1 of 2023Once the IND is open, Incannex will commence pivotal, multi-site Phase 2/3 clinical trials investigating the effects of IHL-42X in patients with OSA over a 12-month periodPhase 2/3 pivotal trials will include between 20 to 30 trial sites, including many in the United States. Sixty-three clinical trial sites have expressed interest in conducting the trial. MELBOURNE, Australia, Nov. 17, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that Incannex has initiated a BA/BE study and is targeting submission of an IND application with the FDA in Q1 2023. The BA/BE study 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 study will be conducted at CMAX Clinical Research in Adelaide, South Australia and managed by Novotech. The design of the BA/BE study is consistent with FDA recommendations for BA/BE and specific advice received by Incannex in the pre-IND meeting. The results of this study 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. In parallel with the BA/BE st...