Incannex Receives Ethics Approval for Bioequivalence/Bioavailability Clinical Trial for IHL-42X, the Company’s Proprietary Drug for Treatment of Obstructive Sleep Apnoea (‘OSA’)

Highlights:

• Incannex has received approval from Bellberry Human Research Ethics Committee (‘HREC’) to commence the bioavailability/bioequivalence (‘BA/BE’) clinical trial to assess the pharmacokinetics and tolerability of IHL-42X
• The trial will include 116 participants at CMAX Clinical Research in South Australia and will be managed by Novotech
• Data from the clinical trial will be a critical component of future marketing submissions for IHL-42X for treatment of OSA
• The trial will be conducted in parallel to the IND opening and pivotal Phase 2/3 clinical trial
• OSA is highly prevalent, affecting approximately 30 million adults in the United States alone and there are no registered prescription drugs available to patients for the treatment of OSA
• The design of the BA/BE trial is consistent with FDA recommendations as part of the required research required to undertake a new drug application.