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Incannex Commences Participant Screening in DReAMzz Phase 2 Study of IHL-42X for Obstructive Sleep Apnea

Globe Newswire•23/07/2026•08:00 ET
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* First clinical sites approved and actively screening potential participants * Represents another major milestone in the advancement of IHL-42X towards Phase III development * IHL-42X has received FDA Fast Track designation, highlighting its potential to address the significant unmet medical need in obstructive sleep apnea and supporting a potentially expedited regulatory pathway * Study designed to optimize both objective sleep metrics and patient-reported outcomes to support regulatory approval and commercial differentiation * Builds upon previously announced positive Phase 2 data demonstrating up to 83% reduction in AHI and significant improvements across multiple patient-reported outcome measures * Obstructive sleep apnea affects an estimated one billion people globally, with no FDA-approved oral pharmaceutical therapies currently available MELBOURNE, Australia and NEW YORK, July 23, 2026 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company developing innovative therapies for high-impact indications, is pleased to announce that participant screening has commenced in the Company’s DReAMzz Phase 2 dose confirmation study evaluating IHL-42X for the treatment of obstructive sleep apnea (“OSA”). IHL-42X has previously been granted Fast Track designation by the U.S. Food and Drug Administration (“FDA”), underscoring its potential to address the significant unmet medical need in OSA and providing opportunities for more frequent interactions with the FDA throughout the development process, supporting a potentially expedited pathway towards regulatory review.

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