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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 assessedLow dose IHL-42X exhibited
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Highlights:\nIHL-42X reduced primary endpoint apnoea hypopnea index relative to baseline at all three doses that were assessedLow dose IHL-42X exhibited superior safety and efficacy metrics to mid and high dosesLow 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 stressIn low dose IHL-42X samples, THC concentrations in blood were well below the limits for impaired driving the morning after dose administrationIHL-42X was well tolerated – low dose IHL-42X was observed to have a lower number of total treatment emergent adverse events than placeboLow dose IHL-42X reduced AHI substantially more effectively than is reported for the component active pharmaceutical ingredients, dronabinol and acetazolamide, as unregistered monotherapies.MELBOURNE, Australia, June 3, 2022 /PRNewswire/ -- Incannex Healthcare Limited (NASDAQ: IXHL) (ASX: IHL), ('Incannex' or the 'Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has completed analysis of data from the phase 2 proof-of-concept clinical trial investigating IHL-42X for treatment of obstructive sleep apnoea ('OSA'). IHL-42X reduced apnoea hypopnoea index ('AHI'), improved patient reported sleep quality and was well tolerated.\nThe clinical trial assessed three doses of IHL-42X at reducing the AHI in patients who suffered from OSA. Data was also collected for other aspects of sleep quality, THC clearance and safety. Trial participants received each of the three doses of IHL-42X and placebo across four seven-day treatment periods, separated by one week washout periods. At the end of each treatment period, 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.\nThe study was conducted at the University of Western Australia Centre for Sleep Science and The Alfred Hospital. A total of eleven participants were recruited to the study and ten participants completed treatment periods. T...