Avextra AG has received approval to launch a Phase 2 clinical trial in Italy to assess its cannabis-based oral medication for managing symptoms associated with amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. The NEUROBIS trial, cleared by the Italian Medicines Agency and the Ministry of Health of Italy, will be conducted at two Italian sites.
NEUROBIS Trial Details
The NEUROBIS trial will randomly assign patients with ALS, Parkinson’s disease, and Alzheimer’s disease to receive either the cannabis-based therapy or a placebo over approximately three years. The trial is sponsored by the AOU Maggiore della Carità in Novara and is funded by the Bando Ricerca Finalizzata through a grant from the Italian Ministry of Health, as part of the National Health Research Program.
"We are excited to support a second Phase II clinical trial NEUROBIS in partnership with a leading university hospital in Italy, the AOU Maggiore della Carità Novara," said Dr. Bernhard Babel, CEO at Avextra. He added that with two active Phase II clinical trials, BELCANTO in Germany and NEUROBIS in Italy, Avextra is uniquely positioned to develop pharmaceutical intellectual property with cannabis-based medicines.
Broader Clinical Efforts
In addition to NEUROBIS, Avextra is collaborating on a Phase 2/3 trial (NCT06097533), named BELCANTO, in Germany. This trial is investigating Avextra’s cannabis-based therapy as part of palliative care for cancer patients.
The approval and funding of the NEUROBIS trial by Italian regulators indicate growing support across Europe for clinical evidence supporting cannabis-based medicines.
Potential Benefits of Cannabis-Based Medicine
The cannabis plant contains over 100 active compounds, including tetrahydrocannabinol (THC) and cannabidiol (CBD). These cannabinoids are known for their psychoactive and calming effects, as well as anti-inflammatory and neuroprotective properties that may help alleviate symptoms of neurodegenerative diseases.
Preclinical and clinical studies suggest that medical cannabis can help manage pain, sleep issues, appetite loss, stiff muscles, and depression in ALS patients. The effects can vary based on the composition of cannabis products, particularly the amounts of THC and CBD.
Addressing Unmet Needs
Avextra aims to develop safe and effective cannabis-based medicines for patients who do not find adequate relief from conventional therapies.
"At our hospital, we observe an increase in the number of individuals affected by dementia, Parkinson’s disease, and ALS who require help with their symptoms," said Dr. Letizia Mazzini, principal investigator for NEUROBIS and director of neurology at AOU Maggiore della Carità. "It is imperative to increase disease awareness and availability of treatment options to address these patient needs."
