A phase II clinical trial of Incannex Healthcare’s novel cannabinoid combination IHL-42X found it led to a substantial reduction in obstructive sleep apnoea (OSA).
The trial assessed three doses of IHL-42X at reducing the apnoea hypopnoea index (AHI), the main diagnostic and monitoring criteria for OSA, compared to a placebo in 10 patients.
Trial participants received three doses of the drug or a placebo across four, seven-day treatment periods, separated by one-week washout periods.
At the end of each, they attended the clinic for an overnight sleep study where AHI was determined, along with other measures of sleep quality, quality of life and drug safety. The study was conducted at the University of Western Australia Centre for Sleep Science and The Alfred Hospital.
Preliminary analysis of the study data found 20% of participants experienced a reduction in the AHI of more than 80% during at least one treatment compared to baseline, while 60% experienced a reduction of more than 50%. The drug was well tolerated.
OSA is the most common sleep-related breathing disorder, causing patients to repeatedly stop and start breathing for long intervals during sleep, and increasing the risk of coronary artery disease, heart attacks, heart failure, and strokes.
Incannex chief scientific officer Dr Mark Bleackley said: “We are delighted that IHL42X has demonstrated efficacy and good safety characteristics in our preliminary assessment of data from the proof-of-concept trial.
“The average reduction in AHI calculated across low, mid, and high-dose IHL-42X has met our expectations for what would constitute a valuable product for the treatment of obstructive sleep apnoea.
“IHL-42X has the potential to reduce disease severity, resulting in improved sleep quality, multiple major health benefits and increased quality of life.”
Incannex is now preparing for a pre-IND meeting with the US Food and Drug Administration on the future development plan for the drug.