Clinical stage pharmaceutical development company Incannex Healthcare (ASX: IHL) has engaged the University of Western Australia’s Centre for Sleep Science as an additional site for an ongoing trial investigating the effects of drug candidate IHL-42X on adults diagnosed with obstructive sleep apnoea (OSA).
Patient recruitment at UWA will run in parallel with The Alfred Hospital in Melbourne where the trial is currently underway, with initial results collected but not yet available for assessment due to blinding.
The trial is now considered a multi-site study with additional medical and scientific staff contributing to its operation.
Incannex received ethics approval in September for the phase 2b dose-finding crossover trial to investigate the effects of cannabinoid-based drug candidate IHL-42X on the apnoea-hypopnea index (AHI).
The index is used to indicate the severity of sleep apnoea in patients and is represented by the number of apnoea (periods of no breathing) and hypopnea (abnormally slow or shallow breathing) events per hour of sleep.
Incannex managing director Joel Latham welcomed the Centre for Sleep Science to the trial.
“We have been impressed with the academic credentials of the team at UWA and their enthusiasm for the potential of IHL-42X as a treatment for OSA,” he said.
“It is the only academic institution in Australia with experience in conducting research on cannabinoids and sleep disorders.”
IHL-42X is a combination drug containing dronabinol (a man-made form of tetrahydrocannabinol, or THC) and other pharmaceutical ingredients.
It has been specifically formulated to potentially improve upon AHI results achieved in other public studies relating to the use of dronabinol when administered to people with OSA prior to night-time sleep. One of those other studies exhibited up to a 50% reduction in AHI in its trial participants in one patient cohort.
Incannex’s randomised, double-blind, placebo-controlled phase 2b trial is assessing the therapeutic benefit of IHL-42X at three different dose levels. The primary endpoint is a reduction in AHI results compared to baseline, or pre-treatment, levels. People in the trial are also being monitored for improvements in alertness, daytime sleepiness, mood and quality of life.
According to Incannex, UWA’s Centre for Sleep Science is a world-class facility with five bedrooms dedicated to research and teaching, and all equipped with state-of-the-art sleep recording and analysis systems.
Research conducted at the centre aims to identify the causes of, and investigate novel therapies for, respiratory and non-respiratory sleep disorders, with the results regularly published in international medical journals and presented at industry meetings.
Teams also collaborate with industry partners to investigate the effects of novel devices and pharmaceuticals for the treatment of OSA and insomnia.
Centre director Dr Jen Walsh said the Incannex trial could offer solutions to a growing problem.
“It is exciting to be working with Incannex on this trial of an alternate treatment option for OSA given the number of people [who suffer from it],” she said.
“Even patients who can tolerate existing therapies [such as continuous positive airway pressure, or CPAP, devices] would sometimes like the option to take a medication rather than sleep with a machine.”
Public health problem
OSA is a major public health problem affecting approximately 30 million adults in the US and creating an annual economic burden in undiagnosed patients of around $189 billion.
According to the American Society of Sleep Medicine, this cost includes $110 billion in lost productivity, $33.2 billion in motor vehicle accidents and $8.25 billion in workplace accidents.
In Australia, Deloitte Access Economics has estimated the direct economic costs due to OSA equate to more than $21 billion per year.
This estimation was made by assessing loss of workdays and morbidity caused by OSA through cardiovascular problems, depression, motor vehicle accidents, workplace accidents and Type 2 diabetes.
OSA increases a patient’s risk of developing numerous health complications, including high blood pressure (hypertension) and cardiovascular morbidity.
The main current treatment option is the mechanical CPAP device, however patient compliance tends to be low due to discomfort and claustrophobia resulting from pressurised air being pumped into the nose or mouth during sleep.
Regardless of this intrusive and uncomfortable mechanical treatment option, the global annual market for OSA detection and treatment using CPAP devices is over $12.6 billion and growing.
There is currently no existing registered pharmacotherapy (drug) treatment option for people with OSA.
Mr Latham said if IHL-42X proves successful under clinical assessment, patient treatment compliance and outcomes could be “greatly improved” from a pharmaceutical product rather than a CPAP device.
The company says any clinical success would “represent a significant market opportunity”.