Incannex Healthcare advances IHL-42X RePOSA trial to Phase 3 after FDA clearance

Incannex Healthcare Inc.

FDA cleared Phase 3 protocol for IHL-42X under IND; trial for obstructive sleep apnea (OSA) with no approved oral therapy.
Phase 3 will be US-only, leveraging Phase 2 infrastructure; ~20 existing sites roll over, 10 new sites added.
Study design: randomized, placebo-controlled, 12 months, including head-to-head against monotherapy components.
Primary endpoint: change in Apnea-Hypopnea Index (AHI); top-line Phase 2 results due in coming weeks.
CEO cites potential to become first FDA-approved oral therapy for OSA; commercial discussions underway.

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