Incannex announces positive results from phase 2 clinical trial investigating the effect of IHL-42X for treatment of obstructive sleep apnoea
Highlights:
• IHL-42X reduced primary endpoint apnoea hypopnea index relative to baseline at all three doses that were assessed
• Low dose IHL-42X exhibited superior safety and efficacy metrics to mid and high doses
• Low dose IHL-42X reduced AHI by an average of 50.7% compared to baseline with 25% of participants experiencing a reduction in the apnoea hypopnea index of greater that 80%
• Oxygen desaturation index was reduced by 59.7% relative to baseline while taking low dose IHL-42X, improving sleep quality and reducing cardiovascular stress
• In low dose IHL-42X samples, THC concentrations in blood were well below the limits for impaired driving the morning after dose administration
• IHL-42X was well tolerated – low dose IHL-42X was observed to have a lower number of total treatment emergent adverse events than placebo
• Low dose IHL-42X reduced AHI substantially more effectively than is reported for the component active pharmaceutical ingredients, dronabinol and acetazolamide, as unregistered monotherapies.