Clinical TrialJul 23, 2026, 07:36 AM
Incannex Starts Phase 2 DReAMzz Study Screening for OSA Drug IHL-42X
AI Summary
Incannex Healthcare Inc. announced the commencement of participant screening for its DReAMzz Phase 2 dose confirmation study evaluating IHL-42X for obstructive sleep apnea (OSA). This marks a significant milestone for the company's lead clinical program, which has already received FDA Fast Track designation. The study aims to optimize dosing and gather further data on objective sleep metrics and patient-reported outcomes, building on previous positive Phase 2 results.
Key Highlights
- Incannex has commenced participant screening for its DReAMzz Phase 2 study of IHL-42X for obstructive sleep apnea (OSA).
- First clinical sites have been approved and are actively screening potential participants for the study.
- IHL-42X has received FDA Fast Track designation, supporting a potentially expedited regulatory pathway.
- The DReAMzz study aims to optimize the dosing profile of IHL-42X and evaluate objective sleep metrics and patient-reported outcomes.
- Previous Phase 2 data showed up to an 83% reduction in Apnea-Hypopnea Index (AHI) and improved patient-reported outcomes.
- Obstructive sleep apnea affects an estimated one billion people globally with no FDA-approved oral pharmaceutical therapies.
- Operational progress includes appointing a global CRO, completing drug manufacturing, and establishing clinical infrastructure.
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