Incannex Healthcare's IHL-42X Achieves Up to 83% AHI Reduction, Wins FDA Fast Track
Incannex's Phase 2 RePOSA trial showed 33.3% and 41.2% of low- and high-dose patients achieved over 30% AHI reduction, with maximum AHI drops of 79% and 83%. The FDA granted Fast Track for IHL-42X, which will enter a Phase 2 dose-optimization study before a streamlined Phase 3 program.
1. Phase 2 RePOSA Efficacy Results
Incannex’s RePOSA Phase 2 trial reported that 33.3% of low-dose and 41.2% of high-dose IHL-42X patients achieved over 30% apnea-hypopnea index reduction, with maximum AHI drops of 79% and 83%. The study showed clinically meaningful symptom improvements and no serious adverse events across both dose groups.
2. Fast Track Designation Accelerates Pathway
The FDA granted Fast Track designation to IHL-42X for obstructive sleep apnea, enabling more frequent meetings and rolling submissions. This status is intended to expedite development and support a more efficient regulatory review process.
3. Upcoming DReAMzz Dose-Optimization Study and Phase 3
Incannex will launch the DReAMzz Phase 2 crossover study to optimize dronabinol and acetazolamide ratios, with dosing expected to begin in coming months under a leading CRO. Data from DReAMzz will inform a streamlined Phase 3 master protocol designed to accelerate timelines and reduce development costs.