Incannex has partnered with The Alfred Hospital in Melbourne to conduct a Phase 2b clinical trial to assess the efficacy of IHL-42X on Obstructive Sleep Apnoea (‘OSA’). Professor Terence O’Brien is the Principal Investigator; a world-renowned clinician and highly experienced Principal Investigator of more than 100 clinical trials. Professor O’Brien heads the Neuroscience Clinical Trials Unit at The Alfred Hospital and has an experienced team of study coordinators and research nurses. The primary endpoint of the clinical trial is the improvement in AHI as measured by an overnight polysomnography (‘PSG’) that will be assessed over multiple weeks.
Secondary outcomes include the following:
- Reduction in oxygen desaturation index (‘ODI’)
- Daytime somnolence measured by the Epworth Sleepiness Scale
- Improvement in mood as measured by the POMS (Profile of Moods State), and well-being as measured by the Short Form 36
- Safety of the IHL-42X combination will be established through adverse event monitoring.
The clinical trial protocol has been to be submitted to the Alfred Health Ethics Committee for review with comments and queries expected back from the ethics committee within the September quarter.
Incannex will endeavour to supply IHL-42X for sale in Australia under the Special Access Scheme for unregistered medicinal cannabis products, alongside its existing range of cannabinoid oils and CBD Inhaler. IHL will also proceed to the second Phase 2 ‘Factorial’ clinical trial as it compiles the necessary information for an FDA 505(b)(2) new drug application for exclusive marketability; details of which were released in the announcement on the 25th of March 2020 and entitled, “IHL-42X (OSA) accelerated FDA approval pathway”. Incannex has filed patents over the use of IHL-42X drug to be delivered to patient as a nocturnally administered pill to treat OSA.
OSA is a lethal disease that increases the risk of numerous health complications, affecting approximately 40M adults in the USA alone and causing an estimated economic burden in excess of $20B per annum. The main current treatment option is the mechanical CPAP device, however, patient compliance to CPAP devices has been proven low due to discomfort and claustrophobia. IHL anticipates greatly improved patient treatment compliance and outcomes from a once-nightly oral pharmaceutical product, such as IHL-42X, should it prove successful under clinical assessment.