Incannex reports results from RePOSA Phase 2 trial of IHL-42X

Incannex (IXHL) Healthcare shared topline results from its RePOSA Phase 2 clinical trial evaluating IHL-42X, a novel oral drug candidate for obstructive sleep apnoea. With over 900 million people affected globally and no approved oral pharmaceutical treatments currently available, IHL-42X’s robust efficacy and exceptional safety profile position it as a potential transformative therapy for OSA patients worldwide. The results confirm statistically significant and clinically meaningful improvements across key endpoints assessed in the study, reinforcing IHL-42x’s potential as a best-in-class therapy for patients with OSA. 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. Notably, 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 Sleep related impairment: The low-dose IHL-42X group showed statistically significant improvement, reflecting meaningful patient-perceived benefits. PGI-C Fatigue: Statistically significant improvement in the low-dose group, suggesting enhanced daytime alertness and reduced fatigue. Oxygen Desaturation Index: Both low- and high-dose groups demonstrated statistically significant improvements, indicating better oxygenation during sleep. Patient-Reported Outcomes: IHL-42X led to clinically significant improvements in patient-reported outcome measures, including the Functional Outcomes of Sleep Questionnaire-10, PROMIS Sleep-Related Impairment 8a, PROMIS Fatigue 7a, and Epworth Sleepiness Scale in both low- and high-dose groups, demonstrating enhanced sleep quality, reduced daytime fatigue, and improved daily functioning for patients with OSA.Polysomnography Metrics: IHL-42X drastically improved objective sleep parameters as measured by PSG. Wake After Sleep Onset: Reduced by 29.8% in the high-dose arm, meaning patients spent less time awake during the night. AHI During Supine Sleep: Decreased by 30.3% in the high-dose arm, a critical improvement given supine sleep exacerbates apneic events. 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 were infrequent, with the majority being mild or moderate in severity. This excellent safety profile supports IHL-42X’s potential for broad patient use. With positive Phase 2 data in hand, Incannex is now focused on advancing IHL-42X toward commercial readiness. Preparations are in progress for the Company’s End-of-Phase 2 meeting with the FDA, where discussions will focus on identifying the most efficient and effective path to registration. This engagement is expected to provide critical guidance for optimising the Phase 3 trial design and regulatory strategy. In parallel, Incannex will continue to evaluate all clinical data and complete the full Clinical Study Report in the coming months. These strategic activities mark a new phase of execution for Incannex as it progresses toward late-stage development and possible future commercialisation.