Ruijian Medicine Announces Completion of Phase I Clinical Trial Enrollment for NouvNeu003, the World’s First iPSC-Derived Dopaminergic Progenitor Cell Therapy for Early-Onset Parkinson’s Disease

Mar 06, 2025 08:21 CST Updated 08:21

iRegene Therapeutics

Cell Therapy Product Developer

Recently, iRegene announced that its self-developed innovative drug NouvNeu003 injection for the treatment of early-onset Parkinson's disease has been successfully advanced under the joint efforts of Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology.Completion of Phase I Clinical Trial Enrollment for All Subjects. This is the world's first dopaminergic precursor cell therapy product for early-onset Parkinson's disease to enter the registration clinical stage. The successful completion of Phase I enrollment for the NouvNeu003 project marks an important milestone in the drug's development, representing a critical step forward in the progress of the Parkinson's disease pipeline.

Unlike typical Parkinson's disease, early-onset Parkinson's disease is characterized by an earlier age of onset, a longer disease course, and significant clinical heterogeneity, making it a more challenging subtype to treat. The Phase I clinical trial, led by Professors Wang Wei, Luo Xiang, and Zhang Huaqiu from Tongji Hospital affiliated with Tongji Medical College, Huazhong University of Science and Technology, has been scientifically and rigorously advanced with a focus on safety validation. The aim is to evaluate the safety and tolerability of the drug in patients with early-onset Parkinson's disease while exploring the cell therapy patterns of NouvNeu003 in this population. Currently, the trial is proceeding smoothly, with participants showing good tolerance to the drug and no serious adverse reactions reported. Initial data aligns with expectations and has preliminarily revealed unique cell therapy patterns for early-onset Parkinson's disease, laying a solid foundation for subsequent confirmatory clinical studies.

iRegene, as the first company in the world to obtain the FDA's "special exemption" qualification for cell therapy, has also become an internationally leading team in the field of Parkinson's disease cell therapy. It ranks first globally in terms of recognition by regulatory authorities, as well as the number, quality, and progress of clinical trials.

Dr. Meng Cai, Chief Medical Officer of iRegene, stated: Early-onset Parkinson's disease, as a rare neurodegenerative disorder, affects patients at a younger age with a faster progression, demanding greater societal attention. There is an urgent need for safer and longer-lasting treatment options. The smooth progress of this Phase I trial demonstrates the profound expertise of the iRegene team and Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, in the field of neurological diseases. Special thanks go to all participants in the clinical trial for their contribution to our work. Moving forward, we will accelerate clinical research to bring breakthrough therapies to patients sooner. The team will continue to observe, collect, and analyze data from the Phase I clinical trial while preparing for subsequent confirmatory clinical studies. We will maintain close communication with regulatory agencies, clinical experts, and patient organizations to ensure that the drug benefits patients worldwide as soon as possible.

E.N.D

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