Incannex Healthcare Inc. announced that an independent Institutional Review Board (IRB) has approved the protocol for the Company's Phase 2/3 clinical trial to be conducted in the United States to assess safety and efficacy of proprietary combination drug candidate IHL-42X in patients with obstructive sleep apnea (OSA). IRB approval of the protocol is a key step in activation of clinical trial sites for the RePOSA study. Under regulations of the Food & Drug Administration, IRB approval is required prior to commencing research in human subjects and serves to ensure that appropriate measures are in place to protect the rights and welfare of research participants.

The approval process involves review of the research protocol, informed consent procedures, recruitment materials, and participant risk versus benefit analysis. 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 naive 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 study is designed to facilitate a seamless transition between Phase 2 and Phase 3, reducing downtime and accelerating development timelines. The endpoints, inclusion criteria and study procedures are the same across both component studies, which streamlines the transition process from Phase 2 to Phase 3. The target patient population is individuals aged 18 years or older with OSA who are tolerant, non-compliant or naive 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. Incannex anticipates greatly improved treatment compliance and outcomes from a pharmaceutical product, such as IHL-42X, subject to further clinical assessment and approval from regulators. Regardless of the discomfort caused by PAP, the global annual market for OSA detection and treatment using PAP and other breathing aides is approximately USD 10 billion per annum and growing2.OSA is highly prevalent, affecting approximately 30 million adults in the United States alone.

It is estimated that the annual economic burden of undiagnosed sleep apnoea among U.S. adults is approximately USD149.6 billion per annum. These costs include USD86.9 billion in lost productivity, USD 26.2 billion in motor vehicle accidents and USD 6.5 billion in workplace accidents.