Incannex announces patient-reported outcomes, efficacy data for IXHL-42X

Incannex (IXHL) Healthcare announced new patient-reported outcome findings from a subset of participants in its RePOSA Phase 2 trial of IHL-42X for the treatment of obstructive sleep apnoea. These new insights, collected through structured exit interviews, add to an already compelling data package highlighting the significant potential of IHL-42X to improve both clinical and patient-centric outcomes in individuals living with OSA. The exit interviews were conducted in alignment with FDA guidance on Patient-Focused Drug Development and aimed to qualitatively assess patient experience, including the impact of IHL-42X on their sleep and quality of life. The interviews were completed prior to unblinding and included subjects from all three arms of the trial-placebo, low-dose IHL-42X, and high-dose IHL-42X. Key findings from the exit interviews include: 57.6% of participants reported a perceived improvement in their OSA; 89.5% of those reporting improvement described the change as meaningful to their lives; Reported benefits included: improved sleep quality, feeling more refreshed in the morning, reduced daytime sleepiness and fatigue, fewer cognitive disturbances, and greater ease in completing daily responsibilities; Patients reported being motivated to participate in the trial due to a desire for improved health, better sleep, and access to alternatives to PAP therapy. These patient insights add important context to the robust clinical data from the RePOSA Phase 2 trial. The RePOSA Phase 2 trial demonstrated clear statistically and clinically significant improvements across multiple key endpoints for patients receiving IHL-42X compared to placebo, highlighting its potential to reduce OSA severity and enhance patient quality of life. Apnoea-Hypopnoea Index: The low-dose and high-dose IHL-42X groups achieved a statistically significant reduction in percent change in AHI from baseline compared to placebo, the primary measure of OSA severity. Maximum reductions in AHI were observed at up to 83% for the high-dose group and up to 79% for the low-dose group. greater than or equal to30% and greater than or equal to50% AHI Reduction Rates: 33.3% of patients in the low-dose group and 41.2% in the high-dose group achieved a greater than 30% reduction in AHI, while 13.9% and 14.7% experienced reductions exceeding 50%-demonstrating a strong therapeutic response in a substantial subset of the population. Patient Global Impression of Change: Statistically significant improvements in sleep-related impairment and fatigue in the low-dose group, reflecting meaningful patient-perceived benefits. Oxygen Desaturation Index: Statistically significant improvements in both low- and high-dose groups, indicating better oxygenation during sleep. Patient-Reported Outcomes: Clinically significant improvements were observed in the Functional Outcomes of Sleep Questionnaire-10, PROMIS Sleep-Related Impairment 8a, PROMIS Fatigue 7a, and Epworth Sleepiness Scale in both dose groups, demonstrating enhanced sleep quality, reduced fatigue, and improved daily function. Polysomnography Metrics: IHL-42X also improved objective sleep parameters including Wake After Sleep Onset, which was reduced by 29.8% in the high-dose arm, and AHI During Supine Sleep, which decreased by 30.3% in the high-dose arm. REM Sleep: IHL-42X did not reduce the proportion of time spent in REM sleep, as measured in the PSGs. This distinguishes IHL-42X from many drugs that are approved for other sleep indications, which are known to reduce the amount of time spent in REM sleep. REM is an important stage of sleep that contributes to memory consolidation, emotional regulation and brain health. These results collectively demonstrate IHL-42X’s ability to address both objective and subjective aspects of OSA, offering compelling clinical benefits to patients. IHL-42X was well tolerated across both low- and high-dose cohorts. No serious adverse events were reported during the treatment period, and treatment-emergent adverse effects (TEAEs) were infrequent, with the majority being mild or moderate in severity. The Company believes this excellent safety profile supports IHL-42X’s potential for broad patient use.