Incannex Healthcare (ASX: IHL) has completed a preliminary analysis of data from a phase 2 clinical trial investigating novel cannabinoid combination drug IHL-42X for the treatment of obstructive sleep apnoea (OSA).
Conducted at the University of Western Australia’s Centre for Sleep Science and Victoria’s The Alfred Hospital, the proof-of-concept trial assessed three doses of IHL-42X and the effects on reducing the apnoea hypopnoea index (AHI), which is the main diagnostic and monitoring criteria for OSA.
Trial participants received each of the three doses and a placebo across four seven-day treatment windows, separated by one-week washout periods.
At the end of each treatment period, participants attended the clinic for an overnight sleep study where their AHI was determined, along with other measures of sleep quality, quality of life and drug safety.
A total of 11 participants were recruited to the trial and 10 completed treatment periods.
Each participant served as their own internal control and inter-participant variation was eliminated.
The study’s crossover design allowed Incannex to generate high quality data with a reduced participant number compared to a conventional parallel arm study.
The study included 10 placebo treatment periods and 26 IHL-42X treatment periods for a total of 36 AHI data points, which were compared to baseline.
For all IHL-42X treatment periods (using low, mid and high doses), the average AHI was 23.81, indicating a 44.4% reduction to the baseline (42.84), while the average during placebo treatment periods was 40.08 (or 6.4% reduction).
Incannex said 60% of participants experienced a reduction in AHI of greater than 55% and a resulting AHI of less than 20 during at least one treatment period of one dose strength of IHL-42X.
During at least on treatment period of one IHL-42X dose strength, 20% of participants experienced a reduction in AHI of greater than 80% (up to 91.5%) relative to baseline.
Specific data from the study – including which IHL-42X doses were received by which patient and when – remained blind.
Patient response to varied IHL-42X doses and the secondary endpoints continue to be analysed by contract research organisation Novotech and will be released to Incannex upon completion.
A full clinical study report is anticipated in before mid-year.
Incannex chief scientific officer Dr Mark Bleackley said the preliminary analysis showed IHL-42X was well tolerated in the clinical trial.
“The average reduction in AHI calculated across the different doses of IHL-42X has met our expectations for what would constitute a valuable product for the treatment of obstructive sleep apnoea,” he said.
“We look forward to further analysis of this data by Novotech, which will include identification of which dose strength performed best.”
OSA is a highly prevalent sleep-related breathing disorder which causes people to repeatedly stop and start breathing for long intervals during sleep.
It is believed to affect approximately 30 million adults in the US alone, with an annual economic burden of $203.96 billion comprising approximately $118.48 billion in lost productivity, $35.72 billion in motor vehicle accidents and $8.86 billion in workplace incidents.
Current standard of care for OSA is a CPAP (or continuous positive airway pressure) machine however patient compliance is low due to discomfort and claustrophobia caused by pressurised air being pumped into the mouth during sleep.
Dr Bleackley said IHL-42X represents a “significant commercial opportunity” for Incannex as there is currently no approved pharmacotherapy treatment available to patients.