Avextra Enrols First Patient in Landmark Italian Trial of Cannabis-Based Medicine
German pharmaceutical company Avextra has enrolled the first participants in its multi-year Phase II clinical trial in Italy, exploring the use of cannabis-based medicine as a ‘supportive treatment’ for patients with amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and Alzheimer’s disease.
Its Phase II study, Neurobis, has been authorised and funded by the Italian Ministry of Health, and is set to study 180 patients over a 36-month period.
As we have covered extensively in the past, the mainstream medical establishment has long called for ‘randomised control trials’ (RCTs) into medical cannabis treatment before considering its wider inclusion in mainstream healthcare.
Neurobis, a randomised, double-blind, placebo-controlled study, will represent yet another feather in the cap of this ‘gold standard’ research in a relatively underresearched area for cannabis treatment.
Notably, Avextra’s extract will be ‘whole-plant’, delivering precise ratios of THC, CBD, and other minor cannabinoids and other plant constituents believed to contribute to broader therapeutic effects.
Earlier this month, Business of Cannabis reported that another German pharmaceutical company, Vertanical, believes it is on course to deliver the first ‘whole-plant’ cannabis medicine with international approval.
Securing regulatory approval for multi-compound, botanical medicines has so far proven to be quite a task, with even market leaders such as Jazz Pharmaceuticals trying and failing to clear this bar in the US with its multiple sclerosis-spasticity treatment Sativex, containing both THC and CBD.
The RCT procedures tend to favour single-compound medicines such as Jazz’s Epidyolex, which contains CBD, and Nabilone containing THC.
The study is set to run for 36-months, and compare Avextra’s standardised full-spectrum cannabis extract with a placebo to evaluate the efficacy of CBMs ‘in terms of quality of life and safety… in neurodegenerative diseases’.
Dr Letizia Mazzini at the ALS Centre in Novara, who will lead the study, suggested that Neurobis reflects a growing interest in exploring medical cannabis as a legitimate therapeutic option for neurodegenerative diseases.
“Thanks to our collaboration with Avextra, we are combining clinical expertise and innovation to rigorously explore the therapeutic potential of medical cannabis,’ she said in a statement.
“The launch of the NEUROBIS study represents a major step forward in our clinical research programme,’ said Avextra CEO Bernhard Babel.
“We are working to improve patients’ quality of life and offer new treatment options based on robust and verified evidence.”
