Cannabinoid-based therapy tested in preclinical study
Gb Sciences gives different doses to rodents, with eye toward trial in humans
The study, which was conducted at the University of Lethbridge, in Canada, tested a range of doses of the investigational therapy, establishing how long it takes each dose to have an effect and how long the effect lasts. Results also suggested the therapy was generally well tolerated, with no safety issues reported.
Buoyed by the data, Gb is planning to file an investigational new drug application — a formal request to the U.S. Food and Drug Administration (FDA) asking for permission to begin clinical testing in humans — as early as next year.
“From this critical study, we have established ranges for the dosage and duration of action in a rodent model that helps us to predict the corresponding and appropriate dose range and duration of action of Gb Sciences’ Parkinson’s disease therapies for our first-in-human trial,” Andrea Small-Howard, PhD, said in a press release. Small-Howard is president, chief science officer and board member at Gb.
Small-Howard added that the study “augments our safety data and suggests that our novel therapeutic may also help alleviate the significant non-motor symptoms of the disease such as problems with sleeping and appetite.”
The cannabis plant, which has been used for millennia as a recreational drug as well as in medical applications, contains many biologically active compounds known as cannabinoids. The two most well-known are tetrahydrocannabinol (THC), which is the main agent responsible for the “high” associated with cannabis use, and cannabidiol (CBD), which is thought to have anti-anxiety and anti-inflammatory properties.
“Gb Sciences is developing a first-in-class, cannabinoid-based treatment for the motor symptoms of Parkinson’s disease,” Small-Howard said.
Gb’s platform uses human-made compounds that have the same activity as cannabinoids, but can be produced with good manufacturing practices, and are present in specific combinations aiming to maximize therapeutic effect and minimize side effects.
Gb Sciences’ compounds
The company’s compounds targeting Parkinson’s are dubbed MEM.PD119, MEM.PD205, and MEM.PD361; Gb has not disclosed the specific combinations of molecules in each of these formulations. The therapies have shown the ability to ease motor symptoms of Parkinson’s in a zebrafish model of the disease.
Gb also is developing cannabinoid-based therapies aiming to treat chronic pain, anxiety, and depression, which are currently in preclinical studies.