Trial testing cannabis-based medicine enrolls first participant
Large Italian study will involve ALS, Parkinson's and Alzheimer's patients
The first participant has been enrolled in a large Italian clinical trial that’s testing Avextra’s cannabis-based medicine for managing symptoms in people with amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.
The NEUROBIS Phase 2 study was cleared to start about a year ago by both the Italian Medicines Agency and the Italian Ministry of Health. The three-year study, which will test the oral medication against a placebo, is being funded by the Ministry of Health.
Led by Letizia Mazzini, MD, a neurologist and researcher with more than 30 years of experience in neurodegenerative diseases, the trial will involve 180 people with either ALS, Parkinson’s disease, or Alzheimer’s disease at sites in Italy, according to a press release from Avextra.
Participants will be randomly assigned to receive the cannabis-based therapy or the placebo for 36 months, with the developer hoping the trial will show that the medication is safe and improves quality of life in people with neurodegenerative diseases.
“We are proud to launch this pioneering clinical trial in Italy,” said Mazzini, who also serves as the director of the ALS Center in Novara.
“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,” Mazzini said. “Our goal is to generate high-quality scientific data that can translate into real clinical benefits.”
Trial assessing ability of cannabis-based medicine to ease patients’ symptoms
Neurodegenerative conditions such as ALS are frequently marked by persistent symptoms that include pain, disrupted sleep, appetite loss, muscle stiffness, and mood changes. Such symptoms are often only partially addressed by existing treatments.
According to Avextra, there’s a need to explore additional options for managing these symptoms. Cannabis-based medicines, particularly when delivered as a full-spectrum extract, represent a promising area of research, the company says.
The cannabis plant has more than 100 active compounds, including the well-known cannabinoids tetrahydrocannabinol, or THC, and cannabidiol, known as CBD. There are also minor cannabinoids and other bioactive compounds.
THC is known for its psychoactive effects and CBD for its calming and anxiolytic properties, but these compounds can also regulate systems involved in pain perception, mood, appetite, and sleep. They also exhibit anti-inflammatory and neuroprotective properties that may help ease certain symptoms of neurodegenerative diseases.
A full-spectrum extract, often known as a whole plant extract, aims to use all the plant’s active compounds, which may act together to support broader therapeutic effects than THC or CBD alone.
We’re working [toward] improving patients’ quality of life and offering new treatment options based on robust and verified evidence.
In people with ALS, medical cannabis has already been shown to help ease several of these symptoms, though the degree of benefit can vary based on each product’s specific CBD to THC ratio.
Avextra is developing a standardized full-spectrum extract, designed to deliver precise levels of THC and CBD.
“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 [toward] improving patients’ quality of life and offering new treatment options based on robust and verified evidence.”
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