Incannex Files Patent for IHL-42X for Obstructive Sleep Apnoea

Incannex (IHL) has this morning announced that it has filed an International Patent Application entitled “Methods for the treatment of obstructive sleep apnoea” as part of the IHL-42X development program. Obstructive Sleep Apnoea (OSA) is a major growing health problem characterised by a narrowing (obstruction) of the upper airway in sleep, interfering with breathing and interrupting sleep. This relatively common health problem is believed to contribute to a wide range of serious long-term outcomes, including cardiovascular disease, cognitive impairments such as memory loss, poor concentration and judgment, depression and death or injury due to traffic accidents resulting from excessive daytime sleepiness. The costs associated with OSA are substantial, relating to lost productivity, workplace, and motor vehicle accidents. The application was filed pursuant to the Patent Cooperation Treaty (PCT) and provides IHL with an opportunity to pursue patent protection in the key markets of North America, the European Union, Japan and Australia. The patent application claims that the IHL-42X formulation of acetazolamide, a registered off-patent pharmaceutical, combined with tetrahydrocannabinol (THC) is a method for the treatment of obstructive sleep apnoea (‘OSA’). An interim analysis of the data from IHL’s ongoing phase 2b double blind randomised placebo-controlled clinical trial was performed and these results have been included in the patent application to support the claims. There are no registered pharmacological solutions (drugs) for OSA with the current standard treatment being a mechanical device which pumps pressurised air into the patient’s nose and/or mouth during sleep and patient compliance is low due to discomfort and claustrophobia. Despite this the annual global market for OSA detection and treatment using continuous positive air pressure devices is over US$10 billion and growing.

Incannex has also received ethic’s approval to commence an open label extension to the Phase 2b clinical trial. The open label extension study will run for a period of 6 months and recruit people who have experienced a benefit from IHL-42X in the Phase 2b trial. It will assess the long-term therapeutic benefit and tolerability of IHL-42X in those patients over an extended timeframe with the primary endpoint being a reduction in Apnoea Hypopnea Index (AHI) compared to the patient’s original, pre-treatment baseline measurement. AHI will be assessed during three overnight sleep studies at day 28, 64 and 168. The main goal of this study is to determine whether the reduction in AHI that was observed for these subjects in the Phase 2b study is maintained over an extended period. Participants will also be monitored for improvements in alertness, daytime sleepiness, mood, and quality of life every 28 days. The safety of the IHL-42X will also be assessed through monitoring of vital signs, serum liver enzymes, blood cell counts and electrolyte levels at each clinic visit.