Incannex Launches DReAMzz Trial Across 14 Sites to Optimize IHL-42X Dosing
Incannex Healthcare has activated infrastructure at all 14 clinical sites and begun the DReAMzz crossover dose optimization trial of IHL-42X in obstructive sleep apnea. The study follows positive Phase II RePOSA results, aims to refine dosing profiles and streamline Phase III design while leveraging FDA Fast Track designation.
1. DReAMzz Trial Commencement
Incannex has activated trial infrastructure at all 14 identified sites, completed IHL-42X manufacturing, secured import/export permits and onboarded a global distribution partner in preparation for patient dosing.
2. Study Design and Objectives
The crossover dose optimization study will refine IHL-42X dosing by evaluating relationships between dose levels, objective sleep metrics and patient-reported outcomes to inform the planned Phase III protocol.
3. Strategic Development Context
Building on statistically significant apnea-hypopnea index reductions and improved sleep quality observed in the Phase II RePOSA trial, the study leverages FDA Fast Track status to de-risk Phase III design and accelerate late-stage development.