Incannex Healthcare Inc. announced that patient dosing has commenced in the Company?s Phase 2/3 clinical trial to assess safety and efficacy of IHL-42X in patients with obstructive sleep apnea (?OSA?). IHL-42X is the Company?s proprietary fixed dose combination drug for treatment of obstructive sleep apnea. Commencement of patient dosing in the United States represents a significant milestone in its development.

Initiating dosing in the trial follows the opening of an Investigational New Drug (IND) application with the FDA and a Phase 2A study completed in 2022 whereby Incannex observed IHL-42X to reduce the apnea hypopnea index (AHI), the standard measure of OSA, by an average of greater than 50% at the low dose in the study. Furthermore, 25% of patients experienced a reduction in AHI of greater than 80%, representing a sub clinical AHI score for some trial participants. The RePOSA study is a Phase 2/3, randomised, double-blind clinical trial to determine the safety and efficacy of IHL-42X in subjects with OSA who are intolerant, non-compliant, or naïve to positive airway pressure (PAP), such as that administered via a continuous positive airway pressure (CPAP) machine.

The RePOSA study consists of two component studies. A four-week Phase 2 dose ranging trial that will determine the optimal dose of IHL-42X based on safety and efficacy in OSA patients, and a 52-week Phase 3 factorial trial that will compare the optimal dose of IHL-42X to the component APIs, dronabinol and acetazolamide, at equivalent doses, as well as placebo. The trial is designed to facilitate a seamless transition between Phase 2 and Phase 3, intended to reduce downtime, accelerating time to commercial product development.

The endpoints, inclusion criteria and study procedures are the same across both component studies, streamlining the transition from Phase 2 to Phase 3. The target patient population is individuals aged 18 years or older with OSA who are intolerant, non-compliant or naïve to Positive Airway Pressure. At least 560 patients will be recruited, with a total of 355 patients receiving IHL-42X over the course of the study.