NEW YORK and MELBOURNE, Australia, June 24, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, announces the appointment of Douglas B. Kirsch, M.D., FAAN, FAASM to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board. “We are honored to welcome Dr. Kirsch to the IHL-42X Clinical Advisory Board,” stated Dr. Lou Barbato, Incannex Chief Medical O ...

Core Insights - Incannex Healthcare Inc. has achieved a significant milestone by locking the database for the RePOSA Phase 2 clinical trial of its lead drug candidate IHL-42X for obstructive sleep apnoea (OSA) as of June 16, 2025, with top-line results expected in July 2025 [1][2][3] Company Overview - Incannex is a clinical-stage biopharmaceutical company focused on developing combination drug therapies for high-impact indications, including OSA, rheumatoid arthritis, and generalized anxiety disorder [8] - The company is advancing three clinical-stage product candidates, with IHL-42X being the lead program designed to target the underlying mechanisms of OSA [8] Drug Development - IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide, currently in the RePOSA Phase 2/3 clinical trial, which aims to enroll over 560 patients globally [5][6] - The drug targets two physiological pathways associated with OSA, specifically intermittent hypoxia and hypercapnia, offering a differentiated approach compared to existing treatments [7] Market Potential - OSA affects over 900 million people worldwide, with growing awareness of its impact on cardiovascular and metabolic health, positioning IHL-42X to potentially disrupt the treatment paradigm [4][6] - Approximately 67% of individuals with OSA are not classified as obese, indicating a broader patient population that could benefit from IHL-42X [7] Clinical Trial Progress - The RePOSA Phase 2 trial is evaluating IHL-42X in patients with moderate to severe OSA who are unable or unwilling to use continuous positive airway pressure (CPAP) [3][4] - Previous studies have shown that IHL-42X can reduce the Apnea-Hypopnea Index (AHI) by an average of 51% relative to baseline in all dosage strengths [6]

Core Insights - Incannex Healthcare Inc. has successfully canceled all remaining Series A Warrants, eliminating potential dilution ahead of key Phase 2 clinical milestones [1][2][3] - The cancellation involved a total of 347.2 million shares, with a financial commitment of $12.2 million for the final tranche [2][3] - The company is preparing for the upcoming topline data readout from its Phase 2 RePOSA trial of IHL-42X for obstructive sleep apnea, expected in July 2025 [3][6] Company Overview - Incannex is a clinical-stage biopharmaceutical company focused on developing combination drug therapies for high-impact indications, including obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder [8] - The lead product candidate, IHL-42X, is an oral fixed-dose combination of dronabinol and acetazolamide, designed to target the underlying mechanisms of obstructive sleep apnea [5][8] - IHL-42X is currently in a Phase 2/3 clinical trial, with over 560 patients expected to be enrolled globally [5][6] Product Details - IHL-42X targets two physiological pathways associated with obstructive sleep apnea: intermittent hypoxia and hypercapnia [6][7] - Previous trials indicated that IHL-42X reduced the Apnea-Hypopnea Index by an average of 51% at the lowest dosage [6] - The product aims to address a significant gap in care for the estimated 1 billion people affected by obstructive sleep apnea globally, particularly those who are not classified as obese [7]