Dual-listed biopharma company Zelda Therapeutics (ASX: ZLD) has kicked off its “pioneering” insomnia trial by dosing its first patient which it says represents a starting point for a wave of research and development that could well spill over into treatments being developed for other ailments.
The trial will be conducted by the University of Western Australia (UWA) Centre for Sleep Science (CSS) with National Health and Medical Research Council senior research fellow Professor Peter Eastwood, named as the trial’s director.
Research conducted at the CSS at UWA aims to identify the underlying causes (and potential therapies) for dislocated sleep patterns.
Zelda intends to leverage the CSS’s state-of-the-art facilities which include five bedrooms equipped with sleep recording and analysis equipment for laboratory-based research sleep studies.
The CSS also contains a range of training and seminar rooms and is currently the working base for a number of national postgraduate sleep training courses offered through the University of Western Australia.
Zelda intends to complete a randomised, placebo-controlled, crossover study treating 24 patients with Zelda’s medicinal cannabis formulation and a placebo formulation delivered sublingually, or in other words, placing its formulation under the tongue.
According to Zelda, the medicine to be used in the trial has been manufactured to “pharmaceutical grade GMP standards” by a European-based speciality manufacturer.
It is hoped the trial will help prove the efficacy of Zelda’s cannabis formulation, with the trial specifically designed to target patients with characteristic symptoms of chronic insomnia, which include difficulty falling and staying asleep on a consistent basis.
Zelda says that once commenced, the trial will collect and analyse data to determine the effect of Zelda’s formulation on the time it takes to fall asleep, time spent awake/asleep during the night, as well as the overall quality of sleep.
The trial will also collect subjective feedback from patients via standard questionnaires, which despite being subjective, will be analysed alongside the raw scientific data.
In a market update published this morning, Zelda said it anticipates reporting its first results “sometime in the first half of 2019.”
If its cannabis formulation performs as Zelda hopes and the trial proves to be successful, the biopharma company intends to rapidly commercialise this formulation “in markets where it is legal to do so,” such as Europe.
“We are delighted with this milestone and look forward to the next phase of the study. Should the trial be successful we see strong potential to provide a safe and effective medicine to patients with insomnia but also potentially for other sleep disorders,” said Professor Peter Eastwood, Director of the Centre for Sleep Science.
As it stands, Zelda has said it will pursue a “two-armed strategy” involving a human clinical trial programme focused on insomnia and autism, to be carried out multilaterally by labs in Australia, Chile and the US.
To complete its insomnia-focused trial, Zelda has partnered with leading cancer cannabis researchers at Complutense University Madrid in Spain to conduct a slew of pre-clinical work testing cannabis-based formulations known to have an effect in humans to generate “data packs in a form expected by regulators and the pharmaceutical industry.”
A similar programme is already in place with the Australian Telethon Kids Institute targeting paediatric brain cancer and Curtin University targeting pancreatic cancer and cognitive decline.
Zelda’s trial is therefore likely to add further clarity regarding the ability of cannabis to serve as a medicinal solution for insomnia and ultimately, could mean its formulations are made available on a commercial basis across Australia and Europe.
“This is a major milestone for Zelda as it represents the first of a number of clinical trials we’re planning to commence over the coming months. Positive data will enable Zelda to accelerate its commercialisation plans, which have been facilitated by our recent agreement with HAPA Medical to manufacture and distribute Zelda products in Germany and Europe.”
Zelda’s market quest
Zelda is focused on developing a range of cannabinoid-based formulations for the treatment of a variety of medical conditions, in addition to the company’s insomnia-focused trial unveiled today.
The company completed its US listing in January this year and has since moved into conducting cannabis trials in paediatric autism and pancreatic cancer research, based on the implementation of cannabis formulations.