Clinical stage cannabinoid development company Incannex Healthcare (ASX: IHL) has partnered with The Alfred Hospital in Melbourne for a phase 2b dose finding crossover trial investigating the effect of lead candidate IHL-42X on adults diagnosed with obstructive sleep apnoea.
The primary endpoint of the trial is an improvement in the apnoea hypopnea index (AHI) as measured by an overnight polysomnography (PSG).
AHI is used to indicate the severity of sleep apnoea and is represented by the number of apnoea (pauses in breathing) and hypopnea (periods of shallow breathing) events per hours of sleep.
In addition to AHI improvements, the trial will record secondary outcomes including a reduction in oxygen desaturation index; daytime somnolence measured by the Epworth Sleepiness Scale; and improvement in mood and well-being as measured psychological and mental health surveys.
Thereafter, Incannex will endeavour to supply IHL-42X for sale in Australia under the Special Access Scheme for unregistered medicinal cannabis products, and alongside its cannabinoid oils and CBD inhaler.
The company will then proceed to a phase 2 ‘factorial’ clinical trial as it compiles the necessary information for a 505(b)(2) FDA new drug application in an attempt to achieve exclusive marketability for the drug.
The onset of COVID-19 and the ensuing lockdown that occurred in March threw doubt over the ability of hospitals around the world to be involved in clinical trial activities of any kind.
Determined to push forward, Incannex initially designed the phase 2b IHL-42X trial around participants based in the home, using portable measuring devices fitted under the instruction of a sleep specialist and to feed sleep data back to a central hub.
As the pandemic’s restrictions began to ease and appropriate management protocols put in place, Incannex identified The Alfred as being a suitable partner and re-designed its trial so that each patient would have their own room for the sleep study, adhering to social distancing rules.
Incannex also announced it will work with Asia-Pacific contract research organisation Novotech to ensure the integrity of the trial and help it meet the requirements of the US Food and Drug Administration in relation to site management, data collection, analysis, and safety monitoring.
Obstructive sleep apnoea is a lethal disease affecting around 40 million adults in the US alone and increasing a patient’s risk of numerous health complications including cardiovascular morbidity.
The main treatment option is the mechanical CPAP (continuous positive airway pressure) device however patient compliance has traditionally been low due to discomfort and claustrophobia caused by the device.
The direct global annual market size for obstructive sleep apnoea detection and treatment using CPAP devices is over $10 billion per annum and growing.
As there is currently no existing registered drug treatment option, Incannex anticipates improved patient treatment compliance from a once-nightly oral pharmaceutical product such as IHL-42X, should it prove successful under clinical assessment.
IHL also stated that the animal study for the assessment of IHL-675A against Sepsis Associated ARDS has been completed, with the results expected from Eurofins Taiwan very soon.
Sepsis Associated ARDS is the leading cause of mortality associated with COVID-19 infection but also from other lung, kidney and skin infections.