First patient enrolled in randomized, placebo-controlled study
Bensheim, 24. October 2025 – Neurodegenerative diseases represent one of the biggest challenges of our time. In Germany alone, there are currently around 1.8 million people living with dementia, a figure that is set to rise to 2.7 million by 2050. Increased life expectancy, combined with the growing number of patients, is having an increasingly significant impact on those affected, their families, and national healthcare systems.
Despite advances in research, there is still a lack of treatment options that are effectively capable of providing symptomatic relief and sustainably improving patients' quality of life.
Within this context, there is a need to develop additional therapeutic options based on robust clinical evidence. Cannabis-based medicines (CbM), particularly in the form of full-spectrum extract, represents a potential area of research due to its potential to modulate the neurophysiological systems involved in degenerative processes.
Toward this objective, the NEUROBIS study is being launched in Italy, a phase II, randomized, double-blind, placebo-controlled clinical trial aimed at evaluating the efficacy in terms of quality of life and safety of CbMs in neurodegenerative diseases.
This 36-month-long clinical trial has been authorized and funded by the Italian Ministry of Health (Ricerca Finalizzata 2022) and involves 180 patients suffering from amyotrophic lateral sclerosis (ALS), Parkinson's disease, or Alzheimer's disease. The first patient has already been enrolled, marking a milestone in clinical research on the use of CBMs as a supportive treatment.
The clinical trial is led by Professor Letizia Mazzini, an internationally renowned neurologist and researcher with over 30 years of experience in the study of neurodegenerative diseases, director of the ALS Center in Novara, and one of Italy's leading experts on motor neuron diseases.
“We are proud to launch this pioneering clinical trial in Italy,” states Professor Mazzini. “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."
Bernhard Babel, CEO of Avextra, highlights the strategic value of this research initiative: "The launch of the NEUROBIS study represents a major step forward in our clinical research program. 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 Avextra
Building trust through research and patient-focused innovation: German biotech company Avextra is committed to advancing cannabis-based prescription medicines. Avextra is investing specifically in research, with six pioneering studies currently being conducted in Germany to pave the way for the regulatory approval we are aiming for. Our goal: to improve the reimbursement of cannabinoids for seriously ill patients in pain management and palliative care in the long term.
Learn more at www.avextra.com and stay up to date at LinkedIn: LinkedIn.com/company/avextra-ag/
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