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Incannex Receives Positive Patient-Reported Outcomes and Compelling Phase 2 Efficacy Data for IHL-42X in Obstructive Sleep Apnoea
Globenewswire· 2025-08-08 12:00
Core Insights - Incannex Healthcare Inc. announced new patient-reported outcomes from its RePOSA Phase 2 trial of IHL-42X for obstructive sleep apnoea (OSA), indicating strong potential for improving sleep quality and cognitive function [1][4] - The exit interviews conducted aligned with FDA guidance and assessed patient experiences, revealing significant motivation among participants for improved health and alternatives to traditional therapies [2][3] Clinical Efficacy - The RePOSA Phase 2 trial showed statistically significant improvements in key endpoints for patients receiving IHL-42X compared to placebo, indicating its potential to reduce OSA severity and enhance quality of life [5] - The Apnoea-Hypopnoea Index (AHI) showed maximum reductions of up to 83% in the high-dose group and 79% in the low-dose group, with both groups achieving statistically significant reductions compared to placebo [6] - 57.6% of participants reported perceived improvements in their OSA, with 89.5% of those describing the changes as meaningful [7] - Reduction rates of ≥30% in AHI were observed in 33.3% of the low-dose group and 41.2% of the high-dose group, while reductions exceeding 50% were seen in 13.9% (low-dose) and 14.7% (high-dose) [8] - Statistically significant improvements in sleep-related impairment and fatigue were noted in the low-dose group, along with better oxygenation during sleep in both dose groups [9] Patient-Reported Outcomes - Clinically significant improvements were observed in various sleep quality metrics, including the Functional Outcomes of Sleep Questionnaire-10 and the Epworth Sleepiness Scale, demonstrating enhanced sleep quality and reduced fatigue [10] - Objective sleep parameters also improved, with a 29.8% reduction in Wake After Sleep Onset (WASO) and a 30.3% decrease in AHI during supine sleep in the high-dose group [11] - IHL-42X did not reduce the proportion of time spent in REM sleep, which is crucial for memory consolidation and emotional regulation [12] Safety Profile - IHL-42X was well tolerated across both low- and high-dose cohorts, with no serious adverse events reported and most treatment-emergent adverse effects being mild or moderate [14] Company Overview - Incannex Healthcare is focused on developing combination medicines targeting chronic conditions, including OSA, rheumatoid arthritis, and generalized anxiety disorder, with IHL-42X being its lead clinical program [15]