Currently being conducted at Lille University Hospital, DIVE is a revolutionary clinical trial on Parkinson's disease. It is based on the development and evaluation of a new system for administering treatment for the disease, which involves injecting the dopamine that is lacking in patients directly into the brain in order to limit the side effects of conventional treatments.
This innovative manufacturing process is being used for the first time at Lille University Hospital. The new technology was developed by InBrain Pharma, a start-up created to exploit the initial concept developed through academic research at Lille University Hospital, the University of Lille, and the Lille Neuroscience & Cognition UMR-S 1172 Inserm laboratory. The technology transfer was carried out by SATT Nord with incubation at Eurasanté.
"Delving into the brain to better treat disease, based on the model of continuous insulin administration in diabetic patients."
Professor David DEVOS, Lille University Hospital, University of Lille, Lille Neuroscience & Cognition – INSERM, and co-founder of InBrain Pharma.
Parkinson's disease: a common neurodegenerative disorder linked to the loss of dopaminergic neurons, responsible for significant motor disorders
Parkinson's disease currently affects 200,000 people in France, including 22,000 cases in the Hauts-de-France region and more than 8 million worldwide. This disease causes a dopamine deficiency in the brain. To compensate for this deficiency, the current treatment is based on repeated oral doses of L-Dopa, which is then converted into dopamine. This has a
limited duration of action and causes severely debilitating motor complications in 50% of patients after 5 years and in 80% of patients after 10 years. Patients then fluctuate constantly between periods of overdose, characterized in particular by uncontrolled movements, periods of good control, and periods of underdose with the resurgence of signs of the disease (slowness, stiffness, tremors, pain, discomfort, anxiety, etc.). At this stage, few second-line treatments can be offered to patients.
The valuable partnership between InBrain Pharma and Lille University Hospital for a new therapeutic solution involving continuous dopamine administration
"Since patients lack dopamine, the ideal treatment would be to deliver it directly to their brains. However, dopamine is a fragile molecule that oxidizes and degrades very quickly when exposed to air. So we came up with the idea of developing a method of administering it in anaerobic conditions (without oxygen to preserve it) and intracerebrally to patients with Parkinson's disease who have reached the stage of complications from oral treatment (i.e., after 5 to 10 years of progression). Called DIVE for Dopamine IntracerebroVentricular, this treatment allows the drug to be delivered directly into the brain to better treat the disease, based on the model of continuous insulin administration in diabetic patients."
Professor David DEVOS, Lille University Hospital, University of Lille, Lille Neuroscience & Cognition Inserm and co-founder of InBrain Pharma
"The anaerobic dopamine solution is produced by the central pharmacy of Lille University Hospital under the supervision of Professor Pascal ODOU, using a unique manufacturing process. It is stored in a pump implanted under the skin in the abdominal region, to which a thin catheter is connected, allowing dopamine to be distributed locally in the cerebral ventricles, thus avoiding peripheral side effects. Our clinical trial conducted by Lille University Hospital has demonstrated excellent results for our patients in terms of feasibility, safety, and clinical effect on
disability control. As a healthcare professional, I am delighted to contribute to the emergence of a new therapeutic solution for the people we support."
Professor Caroline MOREAU, Lille University Hospital, University of Lille, Lille Neuroscience & Cognition Inserm, and co-founder of InBrain Pharma
Initial clinical results confirm improved ergonomics compared to current pump treatments, high safety, and a very promising clinical effect.
The clinical trial, currently underway at Lille University Hospital, compares the DIVE solution with conventional patient treatment (NCT04332276). The results are reported in diaries completed by patients at home and in their everyday lives over several weeks. Even at moderate doses of around 100 mg/24 hours, a clear reduction in the effects of overdose of more than 50% is observed, with a doubling of the ideal control period. With higher doses close to 200 mg/24 hours, control of motor fluctuations appears to be even greater, with an ideal control period of around 80%.