IXHL · Incannex Healthcare Limited

Incannex Healthcare Inc. has reached a pivotal operational milestone by officially commencing the DReAMzz clinical study, a crossover dose optimization trial for its lead candidate IHL-42X targeting obstructive sleep apnea (OSA). This advancement follows the positive Phase II RePOSA trial, where IHL-42X showed statistically significant reductions in apnea-hypopnea index (AHI), improved oxygenation, sleep quality, and patient-reported outcomes. The DReAMzz study aims to refine the dosing profile and strengthen the Phase III design, potentially providing a more efficient registration pathway and supporting capital-efficient development. Key preparations include identification of all 14 clinical sites with expertise in sleep medicine and patient recruitment, completion of drug product manufacturing, securing of import/export permits, and onboarding of a global distribution partner. Site contracting is underway, leveraging high-recruiting sites from RePOSA to enable rapid activation. The FDA's prior Fast Track designation underscores the program's potential to address unmet needs in OSA, a condition affecting hundreds of millions globally with limited effective oral therapies. This progress positions IHL-42X as a leading oral pharmacotherapy candidate, enhancing Incannex's pipeline in high-impact indications.