Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has received clearance from the US Food and Drug Administration (FDA) to begin the Phase 2/3 clinical trial for its IHL-42X asset, designed to address obstructive sleep apnoea (OSA).
The clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic-assisted psychotherapies for unmet needs received the approval after submitting an Investigational New Drug (IND) application to the FDA last month.
The FDA deemed the clinical trial as safe to proceed following an assessment of the trial protocol, lead trial investigators, and a risk-benefit analysis of the trial and prospective product.
With the milestone approval in the bag, Incannex will proceed with the finalisation of institutional review board applications and submissions for the lead clinical trial sites.
Assessing sleep outcomes
The trial will be a multi-centre study examining the effectiveness of IHL-42X for the treatment of OSA in patients who are non-compliant, intolerant, or naïve to positive airway pressure treatment such as that administered by continuous positive airway pressure (CPAP) devices.
Participants will receive one dose of IHL-42X, dronabinol, acetazolamide or placebo following during the 52-week treatment period.
Throughout the trial, participants will complete daily surveys on their sleep quality and attend monthly clinic visits to assess functional outcomes of sleep, cognitive function and other measures of safety and efficacy.
Polysomnography will be conducted every three months to evaluate the effect of treatment on the patients' Apneoa Hypopnea Index score (AHI) and other sleep parameters.
All drug treatments will be compared to placebo.