Avextra AG, a leading European manufacturer of cannabis-based medicines, has received formal approval from the Italian Medicines Agency (AIFA) and the Ministry of Health to begin a multi-centre Phase II clinical trial aimed at treating neurodegenerative diseases. The trial, known as NEUROBIS, will focus on evaluating the safety and efficacy of an oral formulation developed by Avextra for patients with Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s Disease, and Parkinson’s Disease.
This trial represents a significant step for cannabis-based medicine in Europe, being one of the few randomised, placebo-controlled, double-blind studies of its kind to be conducted at multiple sites across Italy. The NEUROBIS study aligns with Avextra’s broader clinical goals of developing safe and effective treatments where existing options may fall short.
Collaboration with Italian Research Institutions
The study is sponsored by AOU Maggiore della Carità, a leading university hospital in Novara, Italy. It will be conducted over a 36-month period at two sites and is funded by a grant from the Italian Ministry of Health under the National Health Research Programme. The trial is led by Professor Letizia Mazzini, a renowned neurologist with over 30 years of experience in clinical research. Prof. Mazzini is also Director of the ALS Regional Expert Centre at the University of Piemonte Orientale, further emphasising the expertise behind this research.
“We are excited to support the NEUROBIS trial in partnership with one of Italy’s top university hospitals,” said Dr. Bernhard Babel, CEO of Avextra. “With two active Phase II clinical trials now underway, including BELCANTO in Germany, Avextra is well-positioned to develop cannabis-based pharmaceutical treatments that have the potential to significantly improve the quality of life for patients with neurodegenerative conditions.”
Addressing Growing Needs
The NEUROBIS trial is driven by preclinical studies and anecdotal evidence suggesting that a specific combination of CBD and THC may help manage symptoms such as pain, sleep disturbances, and psychological stress in patients suffering from ALS, Alzheimer’s, and Parkinson’s. Current treatment options for these diseases often fall short in addressing such symptoms, highlighting the need for new, innovative approaches.
“As a reference centre for neurodegenerative diseases, we have seen a rise in patients with ALS, Parkinson’s, and Dementia who struggle with symptom management. There is an urgent need for more treatment options, and we are grateful to Avextra for supporting this important clinical research,” said Prof. Mazzini.
The NEUROBIS study reflects a wider interest among European regulators in building scientific evidence for cannabis-based medicines. Both the approval and funding of the trial underscore the growing support for investigating the therapeutic potential of cannabis in managing neurodegenerative diseases.
Avextra’s Broader Clinical Plan
The NEUROBIS trial is part of Avextra’s larger clinical strategy to develop evidence-based cannabis treatments, including working towards regulatory approval for cannabis-based medicines under the European Medicines Agency (EMA). Avextra is committed to working closely with the medical community, regulators, and other stakeholders to drive forward innovation in this field.
In addition to the NEUROBIS trial, Avextra is also involved in the BELCANTO study in Germany, further cementing its role as a key player in the development of pharmaceutical cannabis treatments aimed at improving patient care and outcomes. Learn more at avextra.com
