Incannex Clinical Trial Shows Notable Reduction In The Apnoea Hypopnoea Index With Novel Cannabinoid Product

Incannex Healthcare Limited IXHL IHL,a clinical-stage pharmaceutical company developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for unmet medical needs, has completed 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').

The 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.

Highlights:

• 20% 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.

Chief scientific officer of Incannex Healthcare, Dr. Mark Bleackley, said; "We are delighted that IHL-42X has demonstrated efficacy and good safety characteristics in our preliminary assessment of data from the proof-of-concept trial. The average reduction in AHI calculated across low, mid, and high-dose IHL-42X has met our expectations for what would constitute a valuable product for the treatment of obstructive sleep apnoea. IHL-42X has the potential to reduce disease severity, resulting in improved sleep quality, multiple major health benefits and increased quality of life. We look forward to the further analysis of the study data by Novotech, which will include identification of which dose strength performed best."

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Photo by Kinga Cichewicz on Unsplash