NEW YORK and MELBOURNE, Australia - Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage pharmaceutical company, has announced that the Phase 3 component of the RePOSA clinical trial for IHL-42X in obstructive sleep apnea (OSA) will proceed following authorization from the U.S. Food and Drug Administration (FDA). The study aims to evaluate the efficacy and safety of IHL-42X, which is being developed as a potential oral therapy for OSA, a condition affecting approximately one billion people worldwide. The Phase 3 trial will be a randomized, placebo-controlled study conducted across 30 U.S. sites, assessing the drug's performance over 12 months with specific endpoints including changes in the Apnea-Hypopnea Index $(AHI)$ and additional metrics related to sleep quality and daytime function. This advancement follows the completion of Phase 2 and utilizes a streamlined study design to enhance operational efficiency.
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