Trial starts for full-spectrum cannabis drug as 1st patient enrolls
Phase 2 study tests Avextra's treatment in Parkinson's, Alzheimer's, ALS
A Phase 2 clinical trial evaluating Avextra’s cannabis-based oral solution’s safety and efficacy in people with Parkinson’s disease and other neurodegenerative disorders has enrolled its first patient.
The medicine used in the NEUROBIS (EUCT 2023-507715-35-02) clinical trial is described as a full-spectrum cannabis extract, meaning it contains the complete range of naturally occurring compounds from the plant. These include the biologically active compounds known as cannabinoids; tetrahydrocannabinol (THC), the main agent responsible for the high feeling associated with cannabis use; and cannabidiol (CBD), which is thought to have anti-anxiety and anti-inflammatory properties.
NEUROBIS, now underway in Italy, expects to enroll 180 patients aged 18 and older with Parkinson’s disease, Alzheimer’s disease, or amyotrophic lateral sclerosis (ALS). Participants will be randomly assigned to receive either a placebo or the full-spectrum cannabis extract. The study’s primary objective is to evaluate the compound’s safety and efficacy, assessed through improvements in quality of life and disease-specific symptom scales.
The trial will run for 36 months. It’s led by Professor Letizia Mazzini, a neurologist at the University of Eastern Piedmont, and supported by funds from the Italian Ministry of Health.
Balanced formulation for broader benefits
“We are proud to launch this pioneering clinical trial in Italy,” Mazzini said in a Avextra press release. “Thanks to our collaboration with Avextra, we are combining clinical expertise and innovation to rigorously explore the therapeutic potential of medical cannabis as an additional option for patients suffering from neurodegenerative diseases. Our goal is to generate high-quality scientific data that can translate into real clinical benefits.”
Medical cannabis refers to the use of cannabinoid-containing products for therapeutic purposes. In Parkinson’s disease, cannabinoids are thought to influence the endocannabinoid system, which plays a role in motor control, inflammation, and neuroprotection. Early research suggests potential benefits for rigidity, sleep disturbances, anxiety, and nonmotor symptoms.
Avextra’s full-spectrum extract provides a balanced THC/CBD formulation. This formulation preserves the plant’s natural composition, which researchers hope may broaden therapeutic benefits compared with single-compound preparations.
“The launch of the NEUROBIS study represents a major step forward in our clinical research program,” said Bernhard Babel, CEO of Avextra. “Thanks to our standardized full-spectrum extract, developed based on the highest quality and consistency standards, we’re working towards improving patients’ quality of life and offering new treatment options based on robust and verified evidence.”
About the Author
