Lead Indication: Obstructive Sleep Apnea (OSA)
IHL-42X is Incannex’s oral fixed dose combination of dronabinol and acetazolamide designed to act synergistically, targeting two different physiological pathways associated with the intermittent hypoxia (IH) and hypercapnia that characterize OSA.
In an Australian Phase 2 clinical trial, IHL-42X was well tolerated and observed to reduce the apnea hypopnea index (AHI) in OSA patients.
A global Phase 2/3 clinical trial investigating the safety and efficacy of IHL-42X is underway with the Phase 2 portion conducted in the U.S. The expanded Phase 3 portion will include sites in the UK and EU. A top-line readout from the U.S. Phase 2 portion of the Phase 2/3 trial is anticipated in the first half of 2025.
In addition, top-line results from an ongoing pharmacokinetic and safety study in Australia are expected in late 2024.
- 560-patient, randomized, double-blind safety and efficacy study
- Dosing started May 2024
- 115-subject, bioavailability and bioequivalence study
- Dosing completed July 2024
- Crossover, safety and efficacy study
- Study completed