Incannex Reports Positive Topline Results from RePOSA Phase 2 Trial of IHL-42X

Core Insights - Incannex Healthcare Inc. announced positive topline results from its RePOSA Phase 2 clinical trial for IHL-42X, a novel oral drug candidate for obstructive sleep apnoea (OSA), highlighting its potential as a transformative therapy for the over 900 million people affected globally [2][5][11] - The trial demonstrated statistically significant and clinically meaningful improvements across key endpoints, reinforcing IHL-42X's potential as a best-in-class therapy for OSA patients [2][3][5] Clinical Efficacy - IHL-42X showed a reduction in the Apnoea-Hypopnoea Index (AHI) by up to 83% in the high-dose group and 79% in the low-dose group, with 33.3% of low-dose and 41.2% of high-dose patients achieving over 30% reduction in AHI [6][10] - Statistically significant improvements were observed in patient-reported outcomes, including sleep-related impairment and fatigue, indicating enhanced quality of life for patients [6][10] Safety Profile - IHL-42X was well tolerated, with no serious adverse events reported and most treatment-emergent adverse effects being mild or moderate, supporting its potential for broad patient use [4][7] Next Steps - Incannex is preparing for an End-of-Phase 2 meeting with the FDA to discuss the path to registration and optimize Phase 3 trial design [8][9] - The company will continue to evaluate clinical data and complete the full Clinical Study Report, marking a new phase toward late-stage development and potential commercialization [9][10] Company Overview - Incannex is focused on developing combination medicines targeting chronic conditions, including OSA, and is advancing multiple clinical-stage product candidates [11]