Incannex Healthcare (ASX: IHL) has received ethics approval for a phase 2b clinical trial to study the therapeutic benefits of its lead drug IHL-42X on patients with obstructive sleep apnoea (OSA).
This is the first trial in the company’s accelerated plan for an FDA new drug application over the patent-protected IHL-42X it developed in conjunction with Dr Sud Agarwal and a notable Melbourne-based sleep specialist.
The randomised, double-blind, placebo-controlled trial will be performed at the Alfred Hospital in Melbourne with the primary endpoint being a reduction in the apnoea hypopnea index (AHI), which measure apnoea events during sleep.
The trial is classified as a cross-over study, meaning participants will receive three different oral doses of the drug plus a placebo over four one-week treatment periods, each separated by a week-long “washout” to allow the drugs to fully clear from the system.
On the final night of each treatment period, patients will visit the hospital’s sleep clinic to have their AHI determined using overnight polysomnography – a diagnostic tool which records brain waves, blood oxygen levels, heart rate and breathing, as well as eye and leg movements during sleep.
Participants will also be assessed for improvements in alertness, daytime sleepiness, mood, and quality of life as secondary endpoints
OSA is a highly-prevalent condition affecting approximately 30 million adults in the US alone and, despite being an uncomfortable condition on a daily basis, it markedly increases the likelihood of severe health complications such as cardiovascular disease, hypertension, stroke, mental illness and even diabetes.
The total annual economic burden of undiagnosed sleep apnoea among the US population has been calculated at approximately US$149.6 billion, including US$86.9 billion in lost productivity, US$26.2 billion in motor vehicle accidents and US$6.5 billion in workplace accidents.
In Australia, Deloitte Access Economics has estimated that the direct economic costs due to OSA equate to more than $21 billion per annum.
The current standard treatment option for OSA patients is the mechanical CPAP (continuous positive airway pressure) device however, long-term patient compliance is notoriously low due to discomfort and claustrophobia resulting from pressurised air being pumped into the mouth during sleep and delivered by a mask worn at night.
With no registered pharmacotherapy (drug) treatment available, Incannex managing director Joel Latham said there exists significant market opportunity for IHL-42X.
“A successful drug treatment would be a paradigm shift in obstructive sleep apnoea and an important step in the right direction for patients who cannot tolerate the CPAP device,” he said.
“We anticipate greatly improved patient treatment compliance and outcomes from a pharmaceutical product, which could be IHL-42X should it prove successful under clinical assessment.”
Also, on Tuesday this week, Incannex announced the appointment of Dr Paul Liknaitzky to its medical advisory board as a scientific officer for a minimum 18-month term, with a period of exclusivity.
He will advise on the research of novel psychiatric agents and associated therapies which could be suitable for use in the treatment of anxiety and depression-related illnesses.
Existing pharmacological options in the field of anxiety and depression treatment are believed to have inadequate response rates and are associated with adverse side effects.
Dr Liknaitzky earned an Honours in Neuroscience and a PhD in psychology from the University of Melbourne. His work examines mechanisms of mental illness and treatment development primarily within depression, anxiety, and addiction research.
He has appointments at St Vincent’s Hospital in Melbourne and other institutions where he has been involved in the emerging field of psychedelic medicine.