Avextra announces the approval of NEUROBIS by the Italian Medicines Agency: A Phase II clinical trial
- The Italian Medicines Agency AIFA and the Italian Ministry of Health have granted formal approval for NEUROBIS; a multi-centre Phase II study to evaluate safety, and efficacy of an Avextra oral cannabinoid formulation for managing the symptoms of patients suffering from neurodegenerative diseases such as ALS, Alzheimer’s disease and Parkinson’s disease.
- NEUROBIS is the second Phase 2 clinical trial supported by Avextra.
- NEUROBIS is one of the few randomised, placebo controlled, double-blind trial with a Cannabis-based medicine to be conducted at multiple sites in Italy and a study of this robust scientific nature aligns perfectly with Avextra’s clinical plan.
- The study is funded by a grant from the Italian Ministry of Health signifying the support of regulators in gathering of clinical evidence for Cannabis-based medicines.
Avextra AG, a European manufacturer and developer of Cannabis-based medicines located in Germany, has announced that both the Italian Medicines Agency AIFA and the Italian Ministry of Health have granted formal approval for a multi-centre Phase II study to evaluate safety, and efficacy of an Avextra oral formulation in managing the symptoms of patients suffering from Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease. The study, being conducted under the name NEUROBIS, is one of the few randomised, placebo controlled, double-blind trials to be conducted with a Cannabis-based medicine at multiple sites in Italy.
Avextra is partnering with the sponsor of NEUROBIS, the AOU Maggiore della Carità in Novara, Italy for a second company-supported Phase II clinical trial. The principal investigator is Prof. Dr. Letizia Mazzini, a Neurologist with over thirty years of experience in clinical research and Director of the Neurology Division at AOU Maggiore della Carità as well as Director of the ALS Regional Expert Centre at Department of Translational Medicine at the University of Piemonte Orientale. The study was funded by the Bando Ricerca Finalizzata through a grant from the Italian Ministry of Health as part of the National Health Research Programme and will be conducted across two sites over a 36-month period.
Preclinical studies and anecdotal evidence suggest that a specific CBD to THC ratio may play a role in managing symptoms such as pain, sleep deficiency and psychological stress for patients suffering from neurodegenerative conditions such as Alzheimer’s, Parkinson’s and Multiple Sclerosis. Avextra is committed to supporting and conducting clinical trials with the objective of developing safe, effective and regulatory approved medicines for patients where available treatment options fall short. Both the approval and the funding of NEUROBIS signify the supportive stance on the part of European regulatory bodies for gathering robust clinical evidence for Cannabis-based medicines.
“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. “With two active Phase II clinical trials in BELCANTO in Germany and NEUROBIS in Italy, Avextra is uniquely positioned with the necessary skills and capabilities to design clinical trials and develop pharmaceutical IP with Cannabis-based medicines with the potential to improve patient’s quality of life.”
At our hospital, which is a reference centre for many neurodegenerative diseases, we observe an increase in the number of individuals affected by Dementia, Parkinson’s disease and ALS who require help with their symptoms. It is imperative to increase disease awareness and availability of treatment options to address these patient needs. As such we are grateful for the support of Avextra with their excellent clinical team and patient-centred approach
Prof. Letizia Mazzini, Principal Investigator for NEUROBIS
NEUROBIS is one component of Avextra’s larger clinical plan to gather the robust evidence to support use of its unregistered products in specific indications as it undergoes development of EMA-Registered Cannabis-based Medicines. The company is dedicated to working in collaboration with the medical community, regulators and other stakeholders to drive evidence-based innovation forward.
About Avextra AG
Avextra is one of Europe’s leading vertically-integrated medical cannabis operators focused on the development and production of regulator-approved medicines. Founded in 2019 and based out of Germany, the company works in close collaboration with doctors and pharmacists and researchers to develop and produce innovative cannabis-based medicines. Avextra controls the entire value chain – from cultivation in Portugal to EU-GMP certified extraction and manufacturing in Germany. Avextra operates across continental Europe through an expansive distribution network of multiple channels and strategically developed assets for these key markets.
