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Incannex observes substantial reduction in AHI in preliminary results of clinical trial assessing IHL-42X in patients with OSA; proceeds to pivotal studies
MELBOURNE, Australia, March 10, 2022 /PRNewswire/ -- Highlights: 20% of trial participants experienced a reduction in AHI of greater than 80% (range: 82.7% to
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"MELBOURNE, Australia, March 10, 2022 /PRNewswire/ --\nHighlights:\n20% of trial participants experienced a reduction in AHI of greater than 80% (range: 82.7% to 91.5%) during at least one treatment compared to baseline 60% of trial participants experienced a reduction in AHI of greater than 50% (range: 55.0% to 91.5%) during at least one treatment compared to baseline Average of low, mid and high-dose IHL-42X reduced AHI in trial participants by 44.4%, compared to baseline IHL-42X was observed to be well tolerated in the clinical trial IHL-42X has the potential to reduce disease severity, resulting in improved sleep quality, multiple major health benefits and increased quality of life The Company has been granted a pre-IND meeting with FDA on May 11, 2022 (U.S. EST) Planning commences for pivotal clinical trials to commence after opening an IND with FDA. Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), ('Incannex' or the 'Company') a clinical-stage pharmaceutical company developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for unmet medical needs, today announced the completion of a preliminary analysis of data from its phase 2, proof-of-concept clinical trial investigating novel cannabinoid combination product, IHL-42X, for the treatment of obstructive sleep apnoea ('OSA').\nThe clinical trial assessed three doses of IHL-42X at reducing the apnoea hypopnoea index ('AHI'), the main diagnostic and monitoring criteria for OSA, compared to placebo in patients who suffered from the disease. 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. The study was conducted at the University of Western Australia Centre for Sleep Science and The Alfred Hospital. \nA total of eleven participants were recruited to the study and ten participants completed treatment periods. The crossover design of the study permitted Incannex to generate high quality data with a reduced participant number compared to a conventional parallel arm study. Each participant serves as their own internal control and inter-particip...