Incannex Healthcare Limited (Nasdaq: IXHL) (IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet needs, is pleased to announce that it has received approval from the US Food and Drug Administration (‘FDA’) to conduct the Company’s Investigational New Drug (‘IND’) opening pivotal IHL-42X Phase 2/3 clinical trial in the United States as planned.
Incannex submitted the IND application on 20 July 2023 and the FDA completed their review of the substantial application package during the allocated 30-day period. Incannex received communication that the FDA review was completed, and the IND-opening clinical trial is deemed safe to proceed following assessment of the trial protocol, lead trial investigators, and a risk benefit analysis of the trial and prospective product. The IND opening trial will assess the effect of IHL-42X in obstructive sleep apnoea patients who are non-compliant, intolerant, or naïve to positive airway pressure treatment, such as that administered by CPAP devices.
Incannex will continue the start-up process for the Phase 2/3 clinical trial. This will include finalisation of institutional review board (IRB) applications and submissions for the lead clinical trial sites. Site selection, approvals and IRB submission for additional study sites will continue in parallel.
In the IND opening Phase 2/3 clinical trial, participants will receive one dose of IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the trial. All participants will complete daily surveys on their sleep quality, attend monthly clinic visits to assess functional outcomes of sleep, cognitive function and other measures of safety and efficacy. Every three (3) months, overnight polysomnography will be conducted to determine the effect of treatment on the patients’ Apnea Hypopnea Index (AHI) along with a range of other sleep parameters. All drug treatments will be compared to placebo.
This announcement has been approved for release to ASX by the Incannex Board of Directors.
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