Investigators are taking the first steps towards human trials on a novel formulation of cannabinoids designed to target Parkinson’s disease.
Gb Sciences, a US-based research and development company, has announced it will begin dosage studies to test its patent-protected cannabinoid-based formulations, in an animal model of Parkinson’s next month.
These studies will determine the dose range of active ingredients that will be used in human trials and will identify potential side effects.
Following the study, which is being conducted with the University of Lethbridge in Canada, the firm plans on filing an Investigational New Drug Application to begin first-in-human clinical trials as early as next year.
As the second-most common neurodegenerative disease, Parkinson’s disease affects around 10 million people worldwide.
The progressive condition occurs when nerve cells in an area of the brain called the substantia nigra become impaired.
Common symptoms include tremors, slowness of movement, stiff muscles and balance and coordination problems, but many patients will also experience other issues such as anxiety and depression, problems sleeping, and problems with memory.
Many Parkinson’s patients have reported promising effects from using medical cannabis, particularly to help with anxiety and agitation.
A survey of almost 2,000 patients living with Parkinson’s disease in the US, found that 70 per cent of respondents used medical cannabis, reporting improvements in pain, anxiety, agitation, and sleep.
Animal studies conducted by the National Research Council of Canada found that Gb Sciences’ formulations achieved statistically significant reductions in motor symptoms associated with the loss of dopamine-producing neurons.
Initial toxicity studies also came back with no significant evidence of adverse effects.
Dr Andrea Small-Howard, president and chief science officer of Gb Sciences, commented: “Our drug discovery process has identified ratio-specific mixtures of cannabinoids that achieved the statistically significant reduction of Parkinsonian movement symptoms in an animal model, thus establishing our proof-of-concept for this therapeutic programme.
“Now, working with the University of Lethbridge, we are taking a major step forward by testing these cannabinoid ratio-specific formulations to establish the dose range for our first-in-human clinical trial.”
To create Gb Sciences’ novel therapies, the company’s goal is to identify ‘minimum essential mixtures’ that retain the efficacy of whole plant extracts, but with the manufacturing and quality control advantages of single ingredient pharmaceutical products.
Gb Sciences uses its novel technology – combined with rigorous high throughput screening of potential combinations of the plant-derived compounds in established cellular models of disease – to determine which minimum essential mixtures from these plant-based materials may be therapeutically beneficial.
These mixtures are then validated and refined in animal models, in preparation for the first-in-human trial.
Dr. Robert Sutherland, PhD, FRSC, professor and chair of the Department of Neuroscience at the University of Lethbridge and director of the Canadian Centre for Behavioural Neuroscience, added: “Gb Sciences is an innovator in drug discovery and development, and they have promising drug candidates for the treatment of Parkinsonian movement disorders.
“With the state-of-the-art behavioural measurement methods at the University of Lethbridge and the exceptional innovative programs, this promises to be an outstanding, productive partnership.
“Using rodent models of PD-motor symptoms, we should be able to predict the appropriate dose range and duration of action of Gb Sciences’ PD therapies for its first-in-human trial.”