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- Impression Healthcare has successfully registered its second clinical trial to investigate the efficacy of IHL-42X on patients suffering sleep apnoea
- 30 patients will take part in the 6-week trial
- It is believed that besides reducing sleep apnoea events, IHL-42X will also improve mood and improve well-being
Impression Healthcare has successfully registered its second clinical trial to investigate the efficacy of its IHL-42X medicinal cannabis formulation on people suffering obstructive sleep apnoea.
The IHL-42X cannabinoid formulation was prepared in full accordance with the Australian Good Manufacturing Practice (GMP) standards with import permits being received for the key pharmaceutical required ingredients.
This upcoming trial will be a Phase 2a randomised controlled clinical trial which is designed to investigate the effects of IHL-42X on the apnoea hypopnea index (AHI).
“Obstructive Sleep Apnoea Syndrome is one of the biggest unmet disease burdens in the western world for which there are no current, proven pharmacological treatments,” Impression Chief Medical Officer Dr Sud Agarwal said.
“CPAP machines with cumbersome face masks and mandibular splints are the mainstay 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.”
A total of 30 patients will take part in the trial, which is expected to take 6 weeks.
Besides examining the effect of IHL-42X on sleep apnoea, a total of 36 secondary outcomes will also be measured focusing on sleep quality and patient mood.
The safety of IHL-42X will also be measured by the number and type of adverse events reported by trial participants.
It’s believed that the active treatment will reduce AHI, improve mood and improve well-being when compared to a placebo.
The recently completed trial agreement has been registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR).
Impression will now formalise approval for a trial from the Human Research Ethics Committee.
Impression is also undertaking other clinical trails to investigate the use of its uniquely formulated medicinal hemp products for the treatment of traumatic brain injury, gum disease, concussion and temporomandibular joint disorder.
Its long-term goal is to continue to develop and launch a series of “pharmaceutical-grade” hemp products in Australia.
The products will then be sold via Australia’s largest distribution network, Cannvalate.
