Dopamine hydrochloride

InBrain Pharma Secures €1.8 Million in Funding for the PERCEPAR Project under France 2030’s “First Factory” Initiative to Industrialize Anaerobic Dopamine Production for Parkinson’s Disease Lille, May 12, 2025 – InBrain Pharma, a clinical stage biotech specialized in therapeutic solution development against neurodegenerative diseases, is thrilled to announce that it has been selected as a winner of the “First Factory” call for projects operated by Bpifrance on behalf of the French State, as part of the France 2030 plan. The funding supports its PERCEPAR project (PERfusion CErébrale de dopamine, a therapeutic innovation for PARkinson’s patients), which aims to industrialize the manufacturing process of anaerobic dopamine (A-dopamine). As part of this initiative, InBrain Pharma has entered a strategic subcontracting partnership with IDD-Xpert, a CDMO (Contract Development and Manufacturing Organization) specializing in the galenic development and production of innovative drugs. Backed by €1.8 million in funding, this pioneering project aims to scale up the anaerobic dopamine production process — initially to produce clinical batches for the upcoming Phase III trial starting in 2026, and later to manufacture commercial batches required for commercialization. Since 2020, A-dopamine has been prepared by the Hospital Pharmacy of Lille University Hospital. The PERCEPAR project represents an important step in InBrain Pharma's scale-up and efforts to bring to market its novel brain infused dopamine, which is already considered essential for advanced Parkinson’s disease management and expected to challenge current therapeutic dogma in this disease. Dr. Véronique Foutel, President of InBrain Pharma, stated: “We would like to thank the French government for selecting our project under the France 2030 ‘First Factory’ call. By partnering with IDD-Xpert, we have found the ideal industrial partner to scale up our manufacturing process and meet the highest quality standards. Together, we will be laying the foundation for a new manufacturing sector dedicated to sterile injectable drugs requiring extremely strict anaerobic conditions. We are also delighted that this industrialization can take place in a French territory renowned for its pharmaceutical excellence and contribute to further strengthening France’s industrial sovereignty in the manufacturing of cutting-edge therapeutic solutions addressing public health priorities.” A Strategic Partnership with IDD-Xpert To set up and develop a GMP-compliant production of A-dopamine, InBrain Pharma has teamed up with IDD-Xpert, a pharmaceutical subcontractor based in Evreux (Eure). Specializing in injectable solutions, IDD-Xpert has cutting-edge expertise in the manufacture of innovative drugs under complex conditions. Anaerobic dopamine production requires rigorous control of oxygen leves, while complying with sterility standards — a technical challenge few CDMOs worldwide can meet. Dr. Matthieu Fisichella, CSO and co-founder of InBrain Pharma, added: “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 is a highly skilled and innovation-driven partner, essential for the success of our unique anaerobic dopamine project.” Laurence Benissan, CEO of IDD-Xpert, commented: “This project highlights the importance of innovation in the pharmaceutical sector and represents a true revolution in Parkinson’s disease patient management. We are proud to contribute to it. Manufacturing A-dopamine 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.” Virginie Fontaine, Health Sector Innovation Manager at Bpifrance, concluded: “We are delighted to support the PERCEPAR development project through France 2030. InBrain Pharma’s unique expertise in cerebral A-dopamine infusion, combined with IDD-Xpert’s manufacturing know-how, makes this an impactful industrial program addressing a major medical need and reinforcing France’s sovereignty. Innovation in central nervous system treatments is a key health priority for the French State.” A Technical Challenge in the Service of a Major Therapeutic Innovation for Advanced Parkinson’s disease Parkinson’s disease, caused by the degeneration of dopaminergic neurons, leads to severe motor impairments due to dopamine deficiency in the brain. Until the recent validation of the clinical proof-of-concept supporting the use of A-dopamine in 2024 by the DIVE-1 study results, only L-Dopa-based drugs or dopaminergic agonists were used in this context, as conventional dopamine does not cross the digestive or blood-brain barrier when swallowed or injected. The InBrain Pharma’s anaerobic dopamine formulation enables a circadian brain infusion of the neurotransmitter, lifting a scientific lock that has held for half a century. At launch, A-dopamine will be reserved to the management of patients who have become refractory to oral antiparkinsonian therapies and subject to inadequate motor symptom control which corresponds to two-thirds of patients with advanced Parkinson’s disease patient pool in major pharmaceutical markets. Consequently, the continuous A-dopamine brain infusion is expected to address a high unmet medical need. Economic and Industrial Impact Beyond short-term job creation, the project’s success could lead to the establishment of a new IDD-Xpert facility dedicated to commercial batch manufacturing. For its part, InBrain Pharma will be expanding its team by recruiting in the fields of the regulatory affairs and the CMC. The PERCEPAR project is the second major milestone achieved by the biotech in recent months, following the publication of the exceptional therapeutic benefit of its drug candidate in Nature Medicine. These two achievements bring the new drug closer to market, with launch scheduled for the beginning of the next decade. About InBrain Pharma InBrain Pharma is positioning itself as a pioneer in personalized medicine in neurology, titrating dopamine in the brain by circadian intracerebroventricular infusion to treat patients with advanced-stage Parkinson’s disease. Founded in 2018, InBrain Pharma is a biopharmaceutical company that holds an exclusive global license from SATT Nord to exploit the patents covering this groundbreaking therapeutic approach for Parkinson’s disease. This innovation is based on the research conducted by Professors David Devos and Caroline Moreau within their academic team 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. InBrain Pharma has also received the University of Lille Foundation Prize, was a winner of the i-Lab competition, and has been supported through the Deeptech initiative. About IDD-Xpert IDD-Xpert is a CDMO (Contract Development and Manufacturing Organization) based in Evreux, France, specializing in galenic development and manufacturing of innovative drugs, particularly injectable solutions for the pharmaceutical and biotechnology sectors. Since its inception in 2012, IDD-Xpert has built a strong reputation for its expertise in formulating small synthetic chemical and biological molecules, meeting the specific needs of 400 mostly international customers while guaranteeing the compliance with the stringent quality standards of the pharmaceutical industry. By collaborating with InBrain Pharma on the PERCEPAR project, IDD-Xpert is making its facilities and know-how available to meet the complex challenge of producing A-dopamine in an anaerobic environment, a rare technological breakthrough requiring highly specific production conditions similar to those already implemented by IDD-Xpert for anticancer projects from French and Swiss biotechs respectively. About the Parkinson’s disease Parkinson’s disease is the fastest-growing neurological disorder in the world, with a prevalence having doubled over the past 25 years. It affects 2.6 million individuals across the five major European markets, the United States, and Japan, with half of these patients being in the advanced stage of the disease. The Parkinson’s disease results from the progressive degeneration of dopaminergic neurons, leading to a dopamine deficiency that causes major motor disability, often accompanied by pain, cognitive-behavioral disorders, and autonomic dysfunction. In advanced disease stage, treatment options are restricted to few device-assisted therapies (DATs), which in practice are used in less than a third of the patients due to either their limited efficacy or their feared invasiveness or their level of discomfort holding a negative impact on patients’ daily lives. Intracerebroventricular (i.c.v.) dopamine infusion is expected to offer an attractive alternative to this limited therapeutic armamentarium and meet a pressing unmet need for effective care. About the “First Factory” Call for Projects Launched in 2022 as part of the France 2030 plan, this initiative—led by the French Directorate General for Enterprise (DGE), in collaboration with the General Secretariat for Investment and operated on behalf of the French State by Bpifrance—is aimed at innovative industrial start-ups and SMEs. Its goal is to accelerate the industrialization of strategic and innovative productions within France. The program is part of the broader effort by the French government to revive industrial sovereignty through the France 2030 Plan and the “Industrial Start-ups” strategy, which seeks to transform France’s research and entrepreneurial excellence into industrial and productive success stories. Innovative players are seen as key drivers of this reindustrialization, particularly in the development of next-generation technologies. About France 2030 ✔ Encompasses a dual ambition: to sustainably transform key sectors of the French economy (such as health, energy, automotive, aerospace, and space) through technological innovation, and position France not just as a player but as a global leader in shaping the world of tomorrow. From fundamental research to the emergence of new ideas and the production of novel goods or services, France 2030 supports the entire innovation lifecycle up to industrialization. ✔ Unprecedented in its scale: €54 billion will be invested to ensure that French companies, universities, and research organizations can successfully lead transitions in strategic sectors. The goal is to empower them to respond competitively to ecological and economic challenges and to foster the emergence of future champions in our fields of excellence. France 2030 is guided by two cross-cutting goals: dedicating 50% of its spending to decarbonizing the economy, and 50% to emerging players and innovation projects with no significant harm to the environment (in line with the “Do No Significant Harm” principle). ✔ A collaborative implementation: designed and deployed in close consultation with economic, academic, local, and European stakeholders to define its strategic directions and flagship actions. Project leaders are invited to submit applications through open, rigorous, and selective procedures to receive support from the French State. ✔ Led by the General Secretariat for Investment on behalf of the Prime Minister and implemented by the French Environment and Energy Management Agency (ADEME), the National Research Agency (ANR), Bpifrance, and the Banque des Territoires. More information: france2030.gouv.fr | Twitter/X: @SGPI_avenir About Bpifrance Bpifrance, the French Public Investment Bank, finances businesses at every stage of their development through loans, guarantees, and equity investments. It also supports companies with their innovation and international expansion projects. Bpifrance facilitates export activity through a wide range of solutions. Its services also include advisory support, a business university, networking opportunities, and acceleration programs tailored to startups, SMEs, and mid-sized companies (ETIs). With 50 regional offices, Bpifrance provides entrepreneurs with a single, close, and effective point of contact to help them meet their challenges. More information: www.bpifrance.fr – https://presse.bpifrance.fr Follow us on X (formerly Twitter): @BpifranceLeLab – @bpifrance – @BpifrancePresse and on LinkedIn – lelab.bpifrance.fr – www.bpifrance.fr Press contact: Florence Portejoie, FP2COM, 06 07 76 82 83, fportejoie@fp2com.fr Attachment InBrain_PR_PERCEPAR_VDEF_20250512