Impression Healthcare Limited ('Impression', 'IHL' or the 'Company') will be conducting the phase 2a of their trials investigating the effect of their cannabis formulation known as IHL-42X that seeks to address Obstructive Sleep Apnoea.
Obstructive Sleep Apnoea is one of IHL's four areas of research alongside Traumatic Brain Injury/Concussion, Periodontitis (Gum Disease) and Temporomandibular Joint Disorder.
The trials will be randomized and controlled, using the Apnoea Hypopnea Index (AHI) and focusing on outcomes measures of sleep quality and patient mood to determine the success of the formulation.
30 participants will be involved in the trial over a 6 week period, with the hopes that the active treatment will reduce AHI while improving the patient's mood and well-being when compared to the placebo. Recruitment for patients is scheduled to commence at the end of September/early October.
IHL has received their import permits for the key active pharmaceutical ingredients necessary for their IHL-42X formulation and has registered the trial protocol on the Australian and New Zealand Clinical Trials Registry ('ANZTCR.') The company will also be formalizing its approval through the Human Research Ethics Committee ('HREC') prior to the recruitment of patients and ensuring that the cannabinoid formulation for IHL-42X meets the Good Manufacturing Practice (GMP) standards in Australia.
On top of measuring IHL-42X on the AHI, the company plans to test a total of 36 secondary outcomes using the Epworth Sleepiness Scale and Insomnia Severity Index, as well as using the Beck Anxiety Inventory and Beck Depression Inventory. The outcomes will all center around sleep quality, and the safety of the formulation will be determined by the number of adverse effects and events experienced by trial participants.
Impression Non-Executive Director and Chief Medical Officer, Dr Sud Agarwal said;
"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.
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."
The trial announcement follows on from the unveiling of IHL's cannabinoid drug discovery brand Incannex Pharmaceuticals which will be working with an EU-based cannibinoid drug design company named Linnea SA. The EU-based company will serve as IHL's supply partner for the base cannabinoid materials in four novel cannabinoid formulations.
Incannex has released a series of pharmaceutical-grade cannabinoid products to be sold through Cannvalate, Australia's largest cannabinoid distribution network, which is likely where the Obstructive Sleep Apnoea Formulation will be sold.
IHL has secured Australian licenses in place to import, export and distribute cannabis products and access to Cannvalate Pty Ltd – the largest network of cannabis medicine prescribers in Australia.
On top of this, the company has a license agreement and Resolution Chemicals in the US, which allows for the production and distribution of Dronabinol – a man-made form of cannabis used to treat appetite loss, severe nausea and vomiting caused by cancer chemotherapy.
Impression Healthcare is continuing to build its growing portfolio of formulations while developing strong partnerships along the way.