Summary: Incannex Healthcare has completed data collection for its U.S.-based phase 2 trial of IHL-42X, a dual-mechanism oral drug for obstructive sleep apnea, with top-line results expected later this month.
Key takeaways:
- IHL-42X combines dronabinol and acetazolamide to address OSA by targeting intermittent hypoxia and hypercapnia.
- Data collection for the US phase 2 RePOSA trial has concluded, with top-line results on track for later this month.
- A prior Australian trial showed that the lowest dose of IHL-42X reduced AHI by an average of 51% from baseline.
- IHL-42X’s mechanism is distinct from weight-loss-based therapies and may suit a broader OSA population, including non-obese patients.
- Completion of database lock signals readiness for final statistical analysis and potential regulatory progress.
Incannex Healthcare Inc has completed data collection for its phase 2 clinical trial of IHL-42X, its lead drug candidate for obstructive sleep apnea (OSA), which remains on schedule for top-line results to be delivered later this month.
This marks a major milestone in the development of IHL-42X, confirming the completion of RePOSA phase 2 clinical data collection and enabling final statistical analysis to begin.
IHL-42X is designed to treat OSA by targeting its underlying pathophysiology. An oral fixed-dose combination of dronabinol and acetazolamide, IHL-42X targets two physiological pathways associated with the intermittent hypoxia and hypercapnia that characterize OSA. In a prior Australian Phase 2 clinical trial, IHL-42X was shown to reduce the apnea-hypopnea index (AHI) in all dosage strengths, with the lowest dose reducing AHI by an average of 51% relative to baseline. The phase 2 portion of REPOSA was conducted in the United States.
“Achieving database lock on schedule demonstrates our strong clinical capabilities and commitment to advancing a much-needed therapy for obstructive sleep apnea,” says Joel Latham, president and CEO of Incannex, in a release.
This achievement builds on positive results from earlier studies and marks the next step in the company’s strategy to commercialise IHL-42X as a first-in-class, market-leading therapeutic solution for OSA.
Unlike weight loss therapies, IHL-42X is uniquely engineered to target two key physiological pathways, intermittent hypoxia and hypercapnia, that underlie the pathology of OSA. By targeting these core mechanisms, IHL-42X offers a differentiated approach that may benefit a wider range of patients, including individuals with OSA who are not classified as obese.
