Avextra's NEUROBIS Approved by Italian Medicines Agency for Phase II Neurodegenerative Disease Trial

The Italian Medicines Agency (AIFA) and the Italian Ministry of Health have officially sanctioned NEUROBIS, a multi-centre Phase II clinical study. This trial aims to assess the safety and efficacy of an Avextra oral cannabinoid formulation in managing symptoms associated with neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s Disease, and Parkinson’s Disease. NEUROBIS stands out as one of the few randomized, placebo-controlled, double-blind trials involving a cannabis-based medicine to be conducted across multiple sites in Italy. This rigorous scientific study aligns with Avextra’s clinical objectives.

Avextra AG, a prominent European manufacturer and developer of cannabis-based medicines headquartered in Germany, announced this significant milestone. Avextra collaborates with AOU Maggiore della Carità in Novara, Italy, which sponsors NEUROBIS. The principal investigator for the study is Prof. Dr. Letizia Mazzini. With over three decades of experience in clinical research, Dr. Mazzini is the Director of the Neurology Division at AOU Maggiore della Carità and the ALS Regional Expert Centre at the University of Piemonte Orientale’s Department of Translational Medicine.

The study, financed by a grant from the Italian Ministry of Health’s National Health Research Program, will be conducted over 36 months at two sites. Preclinical studies and anecdotal evidence indicate that a specific CBD to THC ratio may be effective in managing symptoms like pain, sleep deficiency, and psychological stress in patients suffering from neurodegenerative conditions such as Alzheimer’s, Parkinson’s, and Multiple Sclerosis. Avextra is steadfast in its commitment to supporting and conducting clinical trials with the goal of developing safe, effective, and regulatory-approved medicines for patients who have limited treatment options.

The approval and funding of NEUROBIS highlight the supportive stance of European regulatory bodies in gathering robust clinical evidence for cannabis-based medicines. "We are thrilled to support a second Phase II clinical trial, NEUROBIS, in collaboration with a leading university hospital in Italy, the AOU Maggiore della Carità Novara," said Dr. Bernhard Babel, CEO of Avextra. "With two active Phase II clinical trials, BELCANTO in Germany and NEUROBIS in Italy, Avextra is exceptionally positioned to design clinical trials and develop pharmaceutical intellectual property with cannabis-based medicines that have the potential to enhance patients' quality of life."

Prof. Letizia Mazzini, the Principal Investigator for NEUROBIS, added, "Our hospital, a reference centre for many neurodegenerative diseases, has seen an increasing number of individuals affected by Dementia, Parkinson’s Disease, and ALS who need help with their symptoms. It is crucial to expand disease awareness and treatment options to address these patient needs. We are grateful for Avextra's support with their excellent clinical team and patient-centred approach."

NEUROBIS is a part of Avextra’s broader clinical agenda to gather substantial evidence to support the use of its unregistered products for specific indications as it progresses towards developing EMA-Registered Cannabis-based Medicines. The company is dedicated to collaborating with the medical community, regulators, and other stakeholders to drive evidence-based innovation forward.

Avextra AG, established in 2019 and based in Germany, is a leading vertically-integrated medical cannabis operator in Europe. The company focuses on developing and producing regulator-approved medicines through close collaboration with doctors, pharmacists, and researchers. Avextra oversees the entire value chain, from cultivation in Portugal to EU-GMP certified extraction and manufacturing in Germany. It operates across continental Europe through a vast distribution network, strategically developed to serve key markets.