Incannex Healthcare Inc. Quarterly Update, Q1 2024

MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Inc. (NASDAQ: IXHL), (‘Incannex’ or the ‘Company’), is pleased to provide quarterly activities update and for the quarter ended 31 March 2024.

Incannex is undertaking various U.S. Food and Drug Administration (‘FDA’) research and development (‘R&D’) programs for cannabinoid pharmaceutical products and psychedelic medicine therapies. The nearest-to-market projects in the Company’s therapeutic pipeline are:

• IHL-42X drug candidate for Obstructive Sleep Apnea (‘OSA’) - Phase 2/3 studies underway.
• IHL-675A drug candidate for Rheumatoid Arthritis (‘RA’) - Phase 2b studies also underway.
• Psi-GAD psilocybin treatment protocol for generalised anxiety disorder: Phase 2b studies commencing following successful Phase 2 proof of concept studies in 73 patients.
• Clarion Clinics - opens first clinic for the provision of psychedelic-assisted psychotherapies in regulatory permissible locations.

IHL-42X for Treatment of Obstructive Sleep Apnea

IHL-42X is Incannex’s proprietary fixed dose combination drug comprising dronabinol and acetazolamide for treatment of OSA, a condition in which a person’s airways are obstructed during sleep. That obstruction results in reduced oxygen uptake, poor-quality sleep and higher risk of heart disease, mental health disorders and accidents due to sleepiness or cognitive impairment. The current standard of care for OSA are positive airway pressure (‘PAP’) devices, however, patient compliance with PAP machines is limited due to patient discomfort. There are no approved drugs for OSA and IHL-42X is designed to fill this unmet need, particularly for patients who are intolerant to PAP machines.

The RePOSA Phase 2/3 Clinical Trial

The FDA provided clearance for the multi-site Phase 2/3 IND opening clinical trial in 2023. The trial, which has been given the name RePOSA, derived from Revealing the Efficacy of IHL-42X use in Patients with OSA, will assess the safety and efficacy of IHL-42X compared to the component active pharmaceutical ingredients, dronabinol and acetazolamide, as well as placebo.

Design of the RePOSA study consists of a Phase 2 dose ranging study that will be conducted at twenty-five sites in the United States. Patients in the Phase 2 study will receive one of two doses of IHL-42X or placebo for 4 weeks. After 4 weeks treatment, the patients will undergo assessment using overnight polysomnography to determine the severity of their sleep apnea, as well as various patient-reported outcomes and blood sample collection to determine the effects of IHL-42X on their sleep quality and the safety of IHL-42X.