Incannex Healthcare Completes Phase 2 Enrollment in RePOSA Phase 2/3 Trial of IHL-42X, an Oral Once-Daily Treatment for Obstructive Sleep Apnea (OSA)

Core Insights - Incannex Healthcare has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study for IHL-42X, aimed at treating Obstructive Sleep Apnea (OSA) [1][4] - IHL-42X is a novel oral fixed-dose combination medicine designed to improve sleep quality by reducing breathing interruptions during sleep [1][3] Company Overview - Incannex Healthcare is focused on developing combination medicines targeting chronic conditions, including OSA, rheumatoid arthritis, and generalized anxiety disorder [14] - The company is advancing three clinical-stage product candidates, with IHL-42X being the lead program [14] Clinical Trial Details - The RePOSA Phase 2/3 study is a randomized, double-blind trial evaluating the safety and efficacy of IHL-42X in patients with mild to severe OSA who are intolerant or non-compliant with positive airway pressure therapy [4][6] - The Phase 2 study involved over 120 patients across 11 sites in the U.S., comparing two dose strengths of IHL-42X to placebo [5] - The Phase 3 expansion study will evaluate the selected dose over 52 weeks, enrolling approximately 440 patients [6] Market Need and Impact - OSA affects more than 54 million adults in the U.S. and 936 million worldwide, with increasing prevalence due to aging populations and lifestyle factors [10] - Current treatment options, such as CPAP devices, face challenges with patient compliance, highlighting the need for effective pharmaceutical alternatives [11] Unique Therapeutic Approach - IHL-42X is the first therapeutic in its class targeting physiological pathways related to airway obstruction and CO2 accumulation, which are characteristic of OSA [3] - Previous trials indicated that IHL-42X could reduce the Apnea-Hypopnea Index (AHI) by an average of 51% relative to baseline [13]