Incannex(US:IXHL) Globenewswireยท2025-05-14 12:00Core Insights - Incannex Healthcare Inc. is advancing its clinical program for IHL-42X, an oral treatment for obstructive sleep apnea (OSA), with significant progress in patient dosing and upcoming data analysis [1][2][8] - The company aims to position IHL-42X as a first-in-class treatment, targeting the underlying mechanisms of OSA, which affects millions globally and is linked to serious health conditions [2][4] - The Phase 2 study has shown promising results, including a 51% average reduction in the Apnea-Hypopnea Index (AHI) at the lowest dose, indicating the potential effectiveness of IHL-42X [5][11] Clinical and Program Updates - Patient dosing for the Phase 2 portion of the Phase 2/3 RePOSA study was completed on May 8, 2025, with follow-up assessments expected to conclude by May 17, 2025, and topline results anticipated in July 2025 [8][9] - The IHL-42X program is designed to target two key physiological pathways associated with OSA, making it suitable for a broader patient population, including the 67% of OSA patients who are not obese [4][11] - The company is preparing for an end-of-Phase 2 meeting with the FDA to discuss results and next steps toward a 505(b)(2) NDA submission [9] Market Position and Future Plans - Incannex is engaging in commercial discussions regarding IHL-42X, reflecting growing interest in the treatment's potential in the OSA market [2][9] - The Phase 3 study will be conducted exclusively in the United States, supported by enthusiasm from U.S. clinical sites and trial participants, with plans to recruit 440 patients [9][10] - IHL-42X is a fixed-dose combination of dronabinol and acetazolamide, designed to act synergistically to address the pathophysiology of OSA [10][12]