Impression Healthcare hones in on sleep apnoea trial with proprietary Dronabinol formulation

Impression Healthcare (ASX: IHL) is on the brink of conducting a sleep apnoea trial with its own variant of the cannabinoid medicine Dronabinol after establishing a supply agreement for the drug and submitting the necessary paperwork with Australian regulators.

The healthcare company said it has entered an agreement with Myoderm North America for the supply of Dronabinol which it expects to receive “within weeks, post receipt of permits”.

In order to put itself on the starting block of conducting the trial, Impression and its partners have applied for an import permit from the Office of Drug Control (ODC) for its first batch of Dronabinol – the key ingredient of a new drug formulation that is hoped will help generate health benefits for a wide range of ailments.

After taking receipt of the batch of Dronabinol, Impression intends to use a portion to conduct its clinical trial of up to 40 participants, but in parallel, it will make a significant amount available for general sale under the Special Access Scheme (SAS) via its existing sales relationship with Australia’s largest distributor of cannabis medicines, Cannvalate.

Currently, around 1 million people (4% of Australians) have symptomatic obstructive sleep apnoea with researchers suggesting this could potentially increase due to an ageing population and rising obesity.

Speaking with Small Caps, Impression chief executive officer Joel Latham said “the CPAP device is currently the best defence against sleep apnoea, however, about half of those who use the CPAP device end up discarding it after only a short period of time because its very uncomfortable and cumbersome. We’re conducting the trial to investigate the use of a simple soft capsule taken before bed to ameliorate the debilitating consequences of this disorder”.

In 2017, the global sleep apnoea devices market was valued at US$5.5 billion (A$7.9 billion) but is considered to be growing steadily on the back of deteriorating lifestyle choices. Scientists define sleep apnoea as a serious sleep disorder that is characterised by interrupted breathing during sleep.

Apnoea is the complete loss of breath for 10 seconds or longer and hypopnoea is defined as a partial loss of breath that lasts 10 seconds or longer. Sleep apnoea increases the risk of health problems, including high blood pressure, stroke, heart failure, diabetes and mental disorders.

Dronabinol path

Traditional Dronabinol applications are to ease the symptoms of loss of appetite in HIV/AIDS sufferers, nausea and vomiting caused by chemotherapy.

However, more recently, published studies have demonstrated that Dronabinol alone can significantly improve sleep apnoea, as measured by the ‘Apnoea Hypopnea Index’.

Following the agreed supply arrangement with Myoderm North America, Impression said that part of the Dronabinol shipment will be used in conjunction with other pharmaceutical ingredients to create a “uniquely formulated product” for the potential treatment of sleep apnoea.

A portion of the Dronabinol will remain unaltered and retained for immediate sale under the SAS for Dronabinol’s traditional indications – mainly in lightening the symptoms for HIV/AIDS patients and existing cancer treatments.

Proprietary formula

To design its unique Dronabinol-infused formulation, Impression is collaborating with the Medical Cannabis Research Collaboration (MCRC), a partnership between medicinal cannabis company Cannvalate and the Swinburne University of Technology.

The prime objective for creating a unique formulation is to enhance the existing understanding of the effect of Dronabinol on sleep apnoea, as understood by the medical profession.

In this morning’s announcement, Impression confirmed the finalised protocol for its clinical trial will be “completed soon” with a further market update to be published when the trial formally commences.

Following the completion of a successful clinical trial, Impression said it intends to assess the potential for further trials and apply for special access scheme sales authorisation for any person with severe sleep apnoea.