Zelda Therapeutics Ltd (ASX: ZLD has announced it has secured regulatory approval to conduct a clinical trial of its cannabis medicines with chronic insomnia patients in Australia.
The trial is expected to commence in the first quarter of next year and patient recruitment should begin shortly. A randomised, placebo controlled, cross over study design will be used, where patients are selected at random to be treated with Zelda’s medicinal cannabis formulation or a placebo. Preliminary results from the trial are expected by Q3 2018.
The medicinal cannabis formulations for the clinical trial won’t be made in Australia, but manufactured by the Netherlands’ Eurofins Sinensis. Details of the cannabinoid profile of the medications have not been disclosed at this point.
The trial will be undertaken by the University of Western Australia (UWA) Centre for Sleep Science (CSS), which is directed by Professor Peter Eastwood of the National Health and Medical Research Council.
“This is a very exciting milestone for Zelda,” said company chairman, Harry Karelis. “We have been meticulously working our way through the regulatory framework to ensure we achieve all necessary approvals. This has been a very rigorous process and has taken some time but we are now very well positioned and are the first to undertake a clinical trial of this nature in Australia.
According to the Sleep Health Foundation, at any given time around 10% of people have at least mild insomnia .A recent report released by the Foundation states the total cost of inadequate sleep in Australia was estimated to be $66.3 billion in 2016 – 17, comprising $26.2 billion in financial costs and $40.1 billion in the loss of wellbeing.
For most people insomnia is a self-resolving and temporary condition, but for some it can be a chronic state and requires medical treatment. However, that comes with risks; especially if sleeping pills are prescribed as they can become habit forming and carry a high risk of addiction.
There has been some evidence emerge from various studies that both tetrahydrocannabinol (THC) and cannabidiol (CBD) can help address insomnia.
Zelda’s main focus areas of research are breast, brain and pancreatic cancer, and insomnia, autism and eczema. In September this year, Zelda Therapeutics reported a small observational trial of the use of medicinal cannabis extracts in treating autism has returned positive results.