Health: This mouthguard maker is now kicking off medicinal cannabis trials
Health & Biotech
Health & Biotech
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Impression (ASX:IHL) told investors this morning it had registered a Phase IIa clinical trial for its drug IHL-42X in patients with obstructive sleep apnoea.
IHL-42X is one of the company’s four cannabinoid formulations, and its safety and efficacy will be measured on 30 participants over a six-week period. Secondary outcome measures are focused on sleep quality and patient mood.
The trial must now pass the Human Research Ethics Committee before it can begin. Impression says patient recruitment is expected to start in late September or early October, followed shortly by dosing.
Impression is hoping that, compared to placebo, the treatment will achieve a reduction on the apnoea hypopnea index (AHI), improve mood and well-being.
A total of 36 secondary outcomes will be measured, focused on sleep quality, using the Epworth Sleepiness Scale and Insomnia Severity Index, and patient mood, as measured by the long-established Beck Anxiety Inventory and Beck Depression Inventory.
IHL shares have been in demand as the company’s medicinal cannabis focus ramps up. The sleep apnoea trial is the second the company has registered, following a Phase IIa trial for gingivitis and periodontitis using cannabidiol mouthwash and toothpaste that was registered in late June.
“Obstructive sleep apnoea syndrome is one of the biggest unmet disease burdens in the Western world for which there is no current, proven pharmacological treatments,” Dr Sud Agarwal, Impression chief medical officer, said.
“CPAP machines with cumbersome face masks and mandibular splints are the mainstay of treatment currently, but if there was a registered medicine which had the potential to reduce the number of apnoeas suffered, this would be an enormous disruption of the sleep device market.”
Shares initially got a slight bump, up 7 per cent to 9.8c, but had fallen down to 9.1c shortly before lunch.
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