First patient enrolled in randomized, placebo-controlled study
Bensheim, October 24, 2025 – Neurodegenerative diseases pose a significant challenge today. In Germany, about 1.8 million people are affected by dementia, and this number is projected to reach 2.7 million by 2050. Longer life expectancies and the increasing number of patients are significantly impacting those affected, their families, and healthcare systems.
Despite research advancements, effective treatments for symptomatic relief and improved quality of life for patients remain limited.
Therefore, developing new therapeutic options based on solid clinical evidence is crucial. Cannabis-based medicines (CbM), particularly full-spectrum extract, show promise due to their potential to influence neurophysiological systems involved in degenerative processes.
The NEUROBIS study, a phase II, randomized, double-blind, placebo-controlled clinical trial, has been initiated in Italy to assess the efficacy and safety of CbMs in treating neurodegenerative diseases, focusing on quality of life.
This 36-month clinical trial, authorized and funded by the Italian Ministry of Health (Ricerca Finalizzata 2022), includes 180 patients with amyotrophic lateral sclerosis (ALS), Parkinson’s disease, or Alzheimer’s disease. The enrollment of the first patient marks a key achievement in research on CBMs as a supportive treatment.
The clinical trial is headed by Professor Letizia Mazzini, a renowned neurologist and researcher with over 30 years of experience in neurodegenerative diseases, director of the ALS Center in Novara, and a leading Italian expert in motor neuron diseases.
“We are proud to launch this pioneering clinical trial in Italy,” says Professor Mazzini. “Through our collaboration with Avextra, we are combining clinical expertise and innovation to rigorously investigate the therapeutic potential of medical cannabis as an additional option for patients with neurodegenerative diseases. Our aim is to produce high-quality scientific data that can lead to tangible clinical benefits.”
Bernhard Babel, CEO of Avextra, emphasizes the strategic importance of the research: “The NEUROBIS study is a significant advancement in our clinical research program. Using our standardized full-spectrum extract, developed with the highest standards of quality and consistency, we are dedicated to enhancing patients’ quality of life and providing new, evidence-based treatment options.”
About Avextra
Avextra, a German biotech company, builds trust through research and patient-focused innovation, committed to advancing cannabis-based prescription medicines. Avextra is specifically investing in research, with six pioneering studies being conducted in Germany to pave the way for regulatory approval. Our goal is to improve the reimbursement of cannabinoids for seriously ill patients in pain management and palliative care in the long term.
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