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Patient dosing commenced in RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea
NEW YORK and MELBOURNE, Australia, May 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"NEW YORK and MELBOURNE, Australia, May 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), 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 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. 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 air way 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 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 FDA for patients with sleep apnea. Therefore, the potential market for IHL-42X is immense, and its success could re...