Incannex Healthcare Inc., a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies, is pleased to announce that patient dosing has commenced in the Company’s Phase 2/3 clinical trial to assess the 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 the 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.
Dr Mark Bleackley, Incannex Chief Scientific Officer, said, “Patient dosing in the RePOSA study represents a critical step forward in the development of IHL-42X for treatment of obstructive sleep apnea. There are currently no registered pharmacotherapies available to patients, and poor compliance to positive airway pressure devices means that many patients with sleep apnea are left untreated or chronically under-treated. IHL-42X has the potential to address this unmet need, improving the direct effects of sleep apnea, as well as the associated long-term health and quality of life impacts on this patient population. We look forward to working with trial sites and investigators to continue to recruit and dose patients in the RePOSA trial”
Joel Latham, Incannex CEO and President, said, “We are thrilled to announce this significant milestone for our company, being the first patient dosing in a major clinical trial assessing our IHL-42X candidate. This achievement marks a pivotal step forward in addressing a significant unmet medical need, as there are no orally administered pharmaceutical products registered with the FDA for patients with sleep apnea. Therefore, the potential market for IHL-42X is immense, and its success could revolutionize the treatment landscape for this serious medical condition. We believe that, if successful, our drug will not only unlock tremendous commercial value but also significantly enhance shareholder value”.
The RePOSA study is a Phase 2/3, randomized, 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 will determine the optimal dose of IHL-42X based on safety and efficacy in OSA patients, and a 52-week Phase 3 factorial trial 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 and accelerate time to commercial product development.
Source: Icannex Healthcare Inc.
