Zelda Therapeutics (ASX:ZLD) has announced that the first patient has received medication in its pioneering insomnia trial.
The clinical trial is being undertaken by the University of Western Australia (UWA) Centre for Sleep Science (CSS). It is directed by Professor Peter Eastwood, National Health and Medical Research Council Senior Research Fellow.
The clinical trial is targeting patients with characteristic symptoms of chronic insomnia. These include difficulty falling and staying asleep on a long-term basis.
A randomised, placebo-controlled, crossover study design will be used to treat 24 patients with Zelda’s medicinal cannabis formulation and a placebo formulation delivered sublingually.
The medicine to be used in the trial has been manufactured to pharmaceutical grade standards by a European-based speciality manufacturer.
The company said the study will collect and analyse data to determine the effect of the Zelda formulation on the time it takes to fall asleep, time spent awake and asleep during the night and quality of sleep. In addition, subjective feedback from patients via standard questionnaires will be collected and analysed alongside the analytical data.
It said preliminary results from this clinical trial will be available in the first half of 2019.
According to Dr Richard Hopkins, managing director of Zelda, “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.”