Incannex Healthcare has initiated screening for its DReAMzz dose confirmation study evaluating IHL-42X for obstructive sleep apnea.
Key takeaways:
- Screening is underway for the DReAMzz phase 2 study of IHL-42X, an investigational oral therapy for OSA with FDA Fast Track designation.
- The randomized, crossover study aims to optimize the dosing profile by evaluating objective sleep metrics alongside patient-reported outcomes.
- Previous phase 2 results showed IHL-42X reduced the AHI by up to 83% compared to placebo.
Incannex Healthcare has started screening potential participants for its DReAMzz phase 2 dose confirmation study, which evaluates the investigational drug IHL-42X for the treatment of obstructive sleep apnea (OSA).
The first group of clinical trial sites has received approval to begin screening, marking a step toward phase 3 development. Potential participants will be identified through site patient databases and public outreach initiatives before undergoing assessments against the study’s predefined inclusion and exclusion criteria.
The DReAMzz study is a randomized, crossover phase 2 trial strategically designed to optimize the dosing profile of IHL-42X. It will evaluate the relationship between objective sleep metrics and patient-reported outcomes. According to the company, patient-reported outcomes are increasingly relevant in regulatory review and commercialization strategies for chronic diseases like OSA, particularly concerning improvements in quality of life, fatigue, and overall well-being alongside objective clinical endpoints.
The current study builds upon previously reported positive phase 2 results for IHL-42X, which demonstrated statistically significant reductions in the apnea-hypopnea index (AHI) versus placebo, with reductions of up to 83% observed. The therapy also showed statistically significant improvements across multiple patient-reported outcome measures, including fatigue and sleep-related impairment, while maintaining a favorable safety profile.
“The commencement of participant screening is another major milestone for the IHL-42X development program and represents the culmination of significant work undertaken by our clinical, regulatory, and manufacturing teams over recent months,” says Joel Latham, president and chief executive officer of Incannex Healthcare, in a release. “We believe IHL-42X has the potential to fundamentally change the treatment paradigm for obstructive sleep apnea. While existing treatment options are often associated with poor patient compliance and there are currently no FDA-approved oral pharmaceutical therapies available for OSA, IHL-42X has already demonstrated compelling efficacy across both objective sleep metrics and patient-reported outcomes in our previous phase 2 study.”
IHL-42X previously received Fast Track designation from the US Food and Drug Administration (FDA), which provides opportunities for more frequent interactions with the agency and supports a potentially expedited pathway toward regulatory review.
“The FDA’s decision to grant Fast Track designation to IHL-42X provides further validation of both the significant unmet medical need in OSA and the potential of our program. Fast Track designation is reserved for therapies intended to treat serious conditions and that have the potential to address unmet medical needs, and we believe it further reinforces the significant opportunity that exists for IHL-42X as we advance towards phase 3 development,” Latham says.
