Incannex Healthcare Inc. Advances IHL-42X RePOSA Trial to Phase 3 Following FDA Protocol Clearance

Core Insights - Incannex Healthcare Inc. has received FDA authorization to proceed with the Phase 3 component of the RePOSA clinical trial for IHL-42X, targeting obstructive sleep apnea (OSA), a condition affecting approximately one billion people globally [1][2][3] Company Overview - Incannex is a clinical-stage pharmaceutical company focused on developing novel combination therapies for chronic conditions, including OSA, rheumatoid arthritis, and generalized anxiety disorder [11] - The lead product, IHL-42X, is an oral fixed-dose combination of dronabinol and acetazolamide designed to target the underlying mechanisms of OSA [11] Clinical Trial Details - The Phase 3 trial will be a randomized, placebo-controlled study evaluating the safety and efficacy of IHL-42X over 12 months in patients with moderate-to-severe OSA [5][9] - The study will also include a 3-month head-to-head comparison against the monotherapy components of IHL-42X to demonstrate the synergistic effect of the combination therapy [5] Strategic Approach - The decision to conduct Phase 3 exclusively in the U.S. is based on the successful recruitment and performance during Phase 2, with approximately 20 U.S. sites expected to transition directly into Phase 3 [4] - The operational infrastructure from Phase 2 will be leveraged to enhance speed and cost efficiency in the upcoming trial [6][8] Expected Outcomes - The primary endpoint of the trial is the change in the Apnea-Hypopnea Index (AHI), a key diagnostic measure for OSA, with secondary endpoints focusing on sleep quality and overall well-being [9][10] - A topline readout from the U.S. Phase 2 portion is anticipated in July 2025, which is expected to provide insights into the drug's efficacy [10]