Incannex Healthcare Officially Commences DReAMzz Clinical Study for IHL-42X in Obstructive Sleep Apnea

About this update from Incannex Healthcare Inc.

Major operational milestone achieved as Incannex advances late-stage development of IHL-42X, with all clinical sites identified and trial infrastructure activated MELBOURNE, Australia and NEW YORK, May 14, 2026 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company advancing innovative combination therapies for high-impact indications, today announced the official commencement of its DReAMzz clinical study evaluating IHL-42X for the treatment of obstructive sleep apnea (OSA). The commencement of DReAMzz represents a major operational and strategic milestone for the Company as it advances IHL-42X toward late-stage clinical development and potential registration pathways. The Company has now completed extensive site feasibility assessments, identified all 14 clinical trial sites, completed manufacturing of IHL-42X drug product, secured all required import and export permits, and onboarded its newly appointed global distribution partner in preparation for site activation and patient dosing. The DReAMzz study is designed as a crossover dose optimization study intended to further refine the dosing profile of IHL-42X and strengthen the design of the planned Phase III development program. The study is expected to generate additional data evaluating the relationship between dose optimization, objective sleep metrics, and patient-reported outcomes, which are becoming increasingly important in both regulatory review and commercial positioning within the OSA market. Importantly, the DReAMzz program is designed to further optimize and de-risk the Phase III pathway following the positive Phase II RePOSA clinical trial, where IHL-42X demonstrated statistically significant and clinically meaningful reductions in apnea-hypopnea index (AHI), alongside improvements in oxygenation, sleep quality, fatigue-related outcomes and broader patient-reported measures. Incannex believes the DReAMMZ study has the potential to provide the Company with a more efficient pathway toward potential registration by optimizing the Phase III design prior to commencement, while also supporting more disciplined and effective capital deployment. In recognition of the significant unmet need in obstructive sleep apnea and the encouraging clinical profile demonstrated by IHL-42X to date, the U.S. Food and Drug Administration (FDA) previously granted IH...

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