Zelda Therapeutics Ltd (ASX: ZLD) (OTC: ZLDAF), an Australian-based bio-pharmaceutical company focused on developing CBD-based medicines, announced the first patient had received medication in its insomnia trial.
The clinical trial is being run by University of Western Australia (UWA) Centre for Sleep Science (CSS), directed by Professor Peter Eastwood, National Health and Medical Research Council Senior Research Fellow.
The trial targets patients with chronic insomnia. A randomized, placebo-controlled study will treat 24 patients with Zelda’s CBD-based formulation and a placebo formulation, delivered sublingually (under tongue). The study will determine the effect on the time it takes to fall asleep, time spent awake, asleep during the night, and quality of sleep. Subjective feedback from patients will also be collected.
Preliminary results are expected in the first half of 2019. Should the trial be successful, Zelda will rapidly commercialize the formulation, facilitated by a recent agreement with HAPA Medical to manufacture, and distribute in Germany and Europe.
Dr Richard Hopkins, Managing Director of Zelda said, “This … represents the first of a number of clinical trials we’re planning over the coming months.”
Zalda has a two-armed strategy comprising:
-A human clinical trial program focused on insomnia and autism, in Australia, Chile and the USA.
-A pre-clinical research program examining the effect of cannabinoids in breast, brain and pancreatic cancer, plus research into using cannabinoids to treat diabetes-associated cognitive decline.
Zelda has also partnered with cancer cannabis researchers at Complutense University Madrid in Spain to conduct pre-clinical work with cannabis-based formulations in humans.
A similar program is in place with the Australian Telethon Kids Institute targeting pediatric brain cancer and Curtin University targeting pancreatic cancer and cognitive decline.
University of Western Australia’s Centre for Sleep Science (CSS) is at the forefront of sleep research aiming to identify the causes of, and therapies for, poor sleep. The CSS is equipped with state-of-the-art equipment for laboratory- based research for sleep studies. Additionally, it’s the main location for postgraduate sleep training courses offered through the University of Western Australia.
Source Zelda press release
Zelda Starts Insomnia Trial