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 pharmacokinetics and tolerability of IHL-42X in 116 participants
• Incannex is well progressed in drafting an Investigational New Drug (‘IND’) Application for submission to the US Food and Drug Administration (‘FDA’) in Q1 of 2023
• Once 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 period
• Phase 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.

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