On Wednesday, Incannex Healthcare Inc. (NASDAQ:IXHL) released topline results from its RePOSA Phase 2 clinical trial evaluating IHL-42X, a novel oral drug candidate for obstructive sleep apnea (OSA), a condition affecting over 900 million people worldwide.
OSA is a common sleep disorder where breathing repeatedly stops and starts during sleep due to a blockage of the upper airway.
The results confirm statistically significant and clinically meaningful improvements across key endpoints.
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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 quality of life.
Key Highlights:
Apnoea-Hypopnoea Index (AHI): The low-dose and high-dose IHL-42X groups achieved a statistically significant reduction in percent change in AHI from baseline compared to placebo (p<0.05), 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.
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% (low-dose) and 14.7% (high-dose) experienced reductions exceeding 50%—demonstrating a strong therapeutic response in a substantial subset of the population.
Patient Global Impression of Change (PGI-C) Sleep-related impairment: The low-dose IHL-42X group showed statistically significant improvement (p<0.05), 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 (ODI): Low- and high-dose groups demonstrated statistically significant improvements, indicating better oxygenation during sleep.
Polysomnography (PSG) Metrics: IHL-42X drastically improved objective sleep parameters as measured by PSG.
Wake After Sleep Onset (WASO): Reduced by 29.8% in the high-dose arm, meaning patients spent less time awake during the night.
AHI During Supine Sleep: It decreased by 30.3% in the high-dose arm, a critical improvement given that 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 (TEAEs) were infrequent, with the majority being mild or moderate in severity.
Next Steps
Incannex is now focused on advancing IHL-42X toward commercial readiness. Preparations are underway for the company's End-of-Phase 2 meeting with the U.S. Food and Drug Administration.
Price Action: IXHL stock is up 24.3% at $1.33 during the premarket session at the last check on Wednesday.
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