Dose-ranging Study of Cannabinoid Mixtures for Rodents Set To Begin

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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Gb Sciences is initiating a dose-ranging study of its investigational cannabinoid-based formulations in a rodent model of Parkinson’s disease next month as a step toward a first-in-human study.

The study will determine the dose range of active ingredients to be used in human trials and potential side effects. The company is planning to file an Investigational New Drug Application with the U.S. Food and Drug Administration to begin human trials next year.

To begin the dose-ranging study, GbS Global Biopharma, the company’s Canadian arm, is teaming up with the University of Lethbridge in Alberta, Canada.

Previous studies in animal models of Parkinson’s revealed that these cannabinoid-containing mixtures could safely ease motor symptoms linked to the loss of dopamine-producing nerve cells, a hallmark of Parkinson’s disease.

“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 program,” Andrea Small-Howard, chief science officer and director of Gb Sciences, said in a press release.

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“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,” Small-Howard said.

The company is creating a pipeline of new medicines based on cannabinoids, the pharmacologically active compounds that give the cannabis plant its medical and recreational properties. These mixtures are less complex than whole plant extracts, making them easier to prepare under quality control standards.

To predict how well the mixtures may work, the company is using an artificial intelligence-based platform called PhAROS along with high-throughput screening in cell models. High-throughput screening uses automated equipment to test a high number of chemicals or their mixtures.

The best working mixtures are then validated and optimized in animal models.

“With the state-of-the-art behavioral measurement methods at the University of Lethbridge and the exceptional innovative programs, this promises to be an outstanding, productive partnership,” Robert Sutherland, PhD, professor and chair of the Department of Neuroscience at the University of Lethbridge, said Sutherland also directs the Canadian Centre for Behavioral Neuroscience and is a board of governors research chair in neuroscience.

Gb Sciences was granted a U.S. patent covering the use of its cannabinoid-containing mixtures for treating neurodegenerative diseases, including Parkinson’s disease, in May 2020.