Incannex commenced participant screening in its DReAMzz Phase 2 dose confirmation study of IHL-42X, advancing the program toward Phase III.
Key Highlights:
- First clinical sites approved and actively screening potential participants, marking transition to active recruitment.
- IHL-42X holds FDA Fast Track designation, supporting more frequent FDA interactions and a potentially expedited path.
- Study designed to optimize dosing and evaluate objective sleep metrics and patient-reported outcomes for regulatory support.
- Builds on prior Phase 2 results showing up to 83% reduction in AHI and significant patient-reported outcome improvements.
- Company completed CRO appointment, manufacturing, permits, and distribution infrastructure to support the study.
Original SEC Filing:
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