The crossover dose optimization study aims to refine the dosing profile of the oral therapy and strengthen the design of the planned phase III development program.
Key takeaways:
- Incannex has initiated the DReAMzz study across 14 clinical trial sites to optimize the dosing profile of IHL-42X for OSA.
- The trial follows the phase II RePOSA study, which demonstrated reductions in the AHI and improvements in patient-reported outcomes.
- The FDA previously granted IHL-42X Fast Track designation to expedite the review of the therapy.
Incannex Healthcare Inc has officially commenced its DReAMzz clinical study evaluating IHL-42X for the treatment of obstructive sleep apnea (OSA).
The DReAMzz study is designed as a crossover dose optimization study intended to further refine the dosing profile of IHL-42X and strengthen the design of the planned phase III development program. The study is expected to generate additional data evaluating the relationship between dose optimization, objective sleep metrics, and patient-reported outcomes, which are becoming increasingly important in regulatory review and commercial positioning within the OSA market.
The program is designed to further optimize and de-risk the phase III pathway following the positive phase II RePOSA clinical trial, where IHL-42X demonstrated statistically significant reductions in the apnea-hypopnea index (AHI), alongside improvements in oxygenation, sleep quality, fatigue-related outcomes, and broader patient-reported measures. IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide designed to target underlying mechanisms and act synergistically in the treatment of OSA.
“This is a significant milestone for Incannex and reflects the substantial operational progress made by the team over recent months,” says Lou Barbato, MD, chief medical officer of Incannex Healthcare Inc, in a release. “We have now transitioned from planning into active execution of the DReAMzz study, with critical infrastructure across manufacturing, logistics, clinical sites, and trial operations established and ready to support the next stage of development.”
Barbato notes that the study is designed to de-risk the phase III pathway following the RePOSA data, adding that the commencement of DReAMzz represents a major step toward addressing the substantial unmet need in the OSA market despite existing treatment approaches.
The company confirmed that all 14 sites selected for the DReAMzz study have been identified following a feasibility review process focused on sleep medicine expertise, patient recruitment capabilities, operational execution, and experience conducting complex overnight sleep studies. Site contracting activities are underway, with contracts in place with high-recruiting sites from RePOSA, enabling activation activities to progress efficiently.
In parallel, Incannex has completed manufacturing activities for the IHL-42X clinical trial supply. Required import and export permits have been secured, allowing the company to distribute clinical material as sites become activated. A newly appointed distribution partner has been fully onboarded to support supply chain management and study logistics.
The US Food and Drug Administration (FDA) previously granted IHL-42X Fast Track designation for the treatment of OSA. The designation is intended to facilitate the development and expedite the review of therapies targeting serious conditions where there is the potential to address an unmet medical need.
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