Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has produced promising results from a Phase 2 clinical trial investigating the efficacy of IHL-42X for treatment of obstructive sleep apnoea (OSA), reducing the apnoea hypopnoea index (AHI) with improved reported sleep quality and a well-tolerated safety profile.
Incannex is a clinical-stage pharmaceutical company developing medicinal cannabinoid-based pharmaceutical products and psychedelic medicine therapies for unmet medical needs.
The trial assessed three doses of IHL-42X against a control placebo across four seven-day treatment periods, separated by one-week washout periods.
Data was also collected for other aspects of sleep quality, tetrahydrocannabinol (THC) clearance and safety.
At the end of each treatment period, patients 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.
Incannex’s treatment successfully reduced primary endpoint AHI relative to baseline at all three doses assessed, exhibiting superior safety and efficacy metrics at mid-to-high doses.
Study results compared to baseline
Low dose IHL-42X reduced AHI by an average of 50.7% compared to baseline, with a quarter of patients experiencing a reduction in AHI of more than 80%.
In addition, patients' oxygen desaturation indexes were reduced by 59.7% relative to baseline while taking low doses of IHL-42X, improving sleep quality and reducing cardiovascular stress.
Importantly, at lower doses THC blood concentrations were well below the limits for impaired driving the morning after the dose was administered.
IHL-42X was also well tolerated, with the lowest dose administered observed to have a lower number of total treatment-emergent adverse events than placebo.
The low dosage treatment was also shown to reduce AHI substantially more effectively than is reported for the active component of pharmaceutical ingredients, dronabinol and acetazolamide, as unregistered monotherapies.