Incannex Receives IRB Approval for Novel Cannabinoid Sleep Apnea Treatment Trial
Australian pharmaceutical company, Incannex Healthcare Inc. (Nasdaq: IXHL), has received independent Institutional Review Board (IRB) approval for a Phase 2/3 clinical trial to assess the safety and efficacy of its proprietary novel cannabinoid combination drug candidate IHL-42X in patients with obstructive sleep apnea (OSA). There are currently no approved pharmacotherapy treatments available to treat OSA.
Incannex has selected trial sites including 24 sites in the United States, 13 in Germany, four in Spain and two in Finland. IRB approval of the protocol allows the US-based sites to proceed with site-specific approval, which is a critical step in site activation.
Highlights
The RePOSA study is a Phase 2/3, randomized, double-blind clinical trial to determine the safety and efficacy of IHL-42X in subjects with OSA who are intolerant, non-compliant, or naïve to positive airway pressure (PAP), such as that administered via a continuous positive airway pressure (CPAP) machine.
The RePOSA study follows a Phase 2 proof-of-concept study which yielded positive results, including reducing participant apnea hypopnea index (AHI) by greater than 50% at the optimal dose, reducing oxygen desaturation index, improving sleep efficiency, and patient reported sleep quality. IHL-42X was well tolerated in the study.
OSA is the most common sleep-related breathing disorder and involves the narrowing of the upper airway during sleep. Untreated OSA leads to serious long-term adverse health outcomes including hypertension, cardiovascular disease, heart attack, cognitive impairments, anxiety and depression, irritability and daytime fatigue increasing the risk of accidents.
About Incannex Healthcare Inc.
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for the treatment of obstructive sleep apnoea (OSA), traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain, among other indications.
U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication under investigation currently has no, or limited, existing registered pharmacotherapy (drug) treatments available to the public and represent major global economic opportunities to Incannex and its shareholders.
Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. The Company holds 20 granted patents and over 30 pending patent applications.
