InBrain Pharma Secures €1.8 Million to Industrialize Anaerobic Dopamine Production for Advanced Parkinson's Disease
核心洞察
InBrain Pharma (搜索) has received €1.8 million from France's "First Factory" initiative to scale up production of anaerobic dopamine (搜索) (A-dopamine (搜索)), a breakthrough therapy for advanced Parkinson's disease (搜索).
The company has partnered with CDMO IDD-Xpert (搜索) to develop GMP-compliant manufacturing processes for A-dopamine (搜索), which enables direct brain infusion of dopamine—overcoming a 50-year scientific barrier.
Clinical batches will support Phase III trials beginning in 2026, with commercial production planned for early next decade, potentially transforming treatment for the two-thirds of advanced Parkinson's patients inadequately controlled by current therapies.
InBrain Pharma (搜索), a clinical-stage biotech focused on neurodegenerative diseases, has secured €1.8 million in funding from the French government's "First Factory" initiative to industrialize the production of anaerobic dopamine (搜索) (A-dopamine (搜索)) for advanced Parkinson's disease (搜索) treatment.
The funding, awarded under France 2030's innovation program operated by Bpifrance (搜索), will support the PERCEPAR project (PERfusion CErebrale de dopamine, a therapeutic innovation for PARkinson's patients) to scale up manufacturing processes for A-dopamine (搜索), which has shown exceptional therapeutic benefit in clinical studies.
"We would like to thank the French government for selecting our project under the France 2030 'First Factory' call," said Dr. Véronique Foutel, President of InBrain Pharma (搜索). "By partnering with IDD-Xpert (搜索), we have found the ideal industrial partner to scale up our manufacturing process and meet the highest quality standards."
Strategic Manufacturing Partnership
InBrain Pharma (搜索) has established a strategic partnership with IDD-Xpert (搜索), a Contract Development and Manufacturing Organization (CDMO) based in Evreux, France. The collaboration aims to develop GMP-compliant production of A-dopamine (搜索), which requires extremely strict anaerobic conditions while maintaining sterility standards—a technical challenge few CDMOs worldwide can meet.
Since 2020, A-dopamine (搜索) has been prepared by the Hospital Pharmacy of Lille University Hospital. The new industrial scale-up will initially produce clinical batches for the upcoming Phase III trial starting in 2026, followed by commercial batches for market launch early in the next decade.
Dr. Matthieu Fisichella, CSO and co-founder of InBrain Pharma (搜索), noted: "After consulting more than 40 pharmaceutical manufacturing experts, we are thrilled to have found the best-suited CDMO for our drug candidate right here in France. IDD-Xpert (搜索) is a highly skilled and innovation-driven partner, essential for the success of our unique anaerobic dopamine (搜索) project."
Breakthrough Treatment for Advanced Parkinson's Disease
Parkinson's disease (搜索) affects 2.6 million individuals across major pharmaceutical markets, with approximately half in advanced stages. The condition results from the degeneration of dopaminergic neurons, causing dopamine deficiency in the brain that leads to severe motor impairments.
Traditional treatments have been limited to L-Dopa-based drugs or dopaminergic agonists, as conventional dopamine cannot cross the digestive or blood-brain barrier when administered orally or via injection. InBrain Pharma (搜索)'s anaerobic dopamine (搜索) formulation enables direct circadian brain infusion of the neurotransmitter through intracerebroventricular (i.c.v.) delivery, overcoming a scientific barrier that has persisted for half a century.
The DIVE-1 study results in 2024 validated the clinical proof-of-concept for A-dopamine (搜索), demonstrating its potential to address a significant unmet medical need. At launch, the therapy will target patients who have become refractory to oral antiparkinsonian therapies and experience inadequate motor symptom control—approximately two-thirds of advanced Parkinson's disease (搜索) patients.
"This project highlights the importance of innovation in the pharmaceutical sector and represents a true revolution in Parkinson's disease (搜索) patient management," said Laurence Benissan, CEO of IDD-Xpert (搜索). "Manufacturing A-dopamine (搜索) under strict anaerobic conditions, in line with Annex 1 of GMP for sterile products, is a bold technical challenge we are confident to meet thanks to our expertise."
Economic and Industrial Impact
The PERCEPAR project represents the second major milestone for InBrain Pharma (搜索) in recent months, following the publication of its drug candidate's therapeutic benefits in Nature Medicine. Beyond immediate job creation, the project's success could lead to the establishment of a new IDD-Xpert (搜索) facility dedicated to commercial batch manufacturing.
InBrain Pharma (搜索) plans to expand its team by recruiting specialists in regulatory affairs and Chemistry, Manufacturing, and Controls (CMC).
Virginie Fontaine, Health Sector Innovation Manager at Bpifrance (搜索), emphasized the strategic importance of the project: "We are delighted to support the PERCEPAR development project through France 2030. InBrain Pharma (搜索)'s unique expertise in cerebral A-dopamine (搜索) infusion, combined with IDD-Xpert (搜索)'s manufacturing know-how, makes this an impactful industrial program addressing a major medical need and reinforcing France's sovereignty."
Addressing Limited Treatment Options
Current device-assisted therapies (DATs) for advanced Parkinson's disease (搜索) are used in less than a third of eligible patients due to limited efficacy, invasiveness concerns, or discomfort affecting daily life. The continuous A-dopamine (搜索) brain infusion is expected to offer an attractive alternative to this limited therapeutic armamentarium.
The technology builds on research conducted by Professors David Devos and Caroline Moreau at the University of Lille, Lille Neuroscience & Cognition UMR-S 1172 INSERM, and Lille University Hospital. In July 2024, Professors Devos and Moreau were finalists for the 2024 European Inventor Award in the Research category, awarded by the European Patent Office.
Founded in 2018, InBrain Pharma (搜索) holds an exclusive global license from SATT Nord to exploit the patents covering this groundbreaking therapeutic approach. The company positions itself as a pioneer in personalized medicine in neurology, titrating dopamine in the brain by circadian intracerebroventricular infusion for advanced-stage Parkinson's disease (搜索) patients.
The France 2030 "First Factory" initiative, launched in 2022, aims to accelerate the industrialization of strategic and innovative productions within France. With €54 billion in total investment, the program supports the entire innovation lifecycle from fundamental research to industrialization, with a focus on transforming key sectors of the French economy through technological innovation.
