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- Incannex (IHL) has started recruitment for its phase 2b clinical trial of IHL-42X, a treatment for obstructive sleep apnea (OSA)
- Patient recruitment follows an approval from the Alfred Health Ethics Committee
- The randomised double-blind trial will assess the drug at three different dose levels
- The study will take place at the Alfred Hospital under the supervision of Professor Terry O’Brien
- It is believed the economic burden of OSA is around US$149.6 billion (around A$200 billion) every year in the U.S. alone
- The primary current treatment is the Continuous Positive Airways Pressure device, which many patients find obtrusive and uncomfortable
- IHL is trading up 3.45 per cent at 15 cents
Pharmaceutical development company Incannex (IHL) has entered the recruitment stage for its IHL-42X phase 2b obstructive sleep apnea (OSA) clinical trial.
The trial follows a recent approval from the Alfred Health Ethics Committee.
The randomised, double-blind placebo-controlled trial will assess the benefits of the drug at three different dose levels. In addition, participants will also be monitored for secondary improvements, including daytime drowsiness, mood and overall quality of life.
The trial is broken up into four different treatment periods, with all participants to receive three drug doses plus a placebo. The treatment periods will be separated by ‘washout’ periods to allow the drugs to clear from the system.
The trial is being performed at the Alfred Hospital under the supervision of principal investigator and epilepsy expert Professor Terry O’Brien. OSA is more prevalent in patients with epilepsy and poor sleep quality has been linked to high seizure frequency.
OSA is proven to increase the risk of hypertension, which in turn increases risk of coronary heart disease, heart attack and stroke. It can also be a contributing factor for Type 2 Diabetes.
It is believed the disease affects approximately 30 million adults in the U.S. alone with the economic burden form lost productivity and motor vehicle & workplace accidents costing around US$149.6 billion (around A$200 billion) every year.
The primary current treatment for OSA is the mechanical Continuous Positive Airway Pressure device. Patient compliance is generally low, however, due to the discomfort and obtrusiveness of the device.
There is currently no registered drug treatment option for sufferers of OSA. IHL anticipates an improved patient compliance from a pharmaceutical product, which could be IHL-42X, should it prove successful under the clinical assessment.
Incannex CEO and Managing Director Joel Latham says “the entire team at Incannex is excited to commence screening for and recruiting its first patients.”
“A successful pharmaceutical solution would be revolutionary to patients with this condition and we look forward to providing updates on the clinical program.”
IHL are trading up 3.45 per cent at 15 cents at 7:47 am AEDT.
