Ruijian Medicine Successfully Launches Clinical Trial of NouvNeu003, a First-in-Class Allogeneic Cell Therapy for Early-Onset Parkinson’s Disease

Aug 17, 2024 12:10 CST Updated 12:10

iRegene Therapeutics

Cell Therapy Product Developer

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Recently, the kick-off meeting for the registration clinical trial of "NouvNeu003 Injection for the Treatment of Early-Onset Parkinson's Disease" was successfully held at Tongji Hospital, affiliated with Tongji Medical College of Huazhong University of Science and Technology. The project is led by Professor Wang Wei, Standing Committee Member of the Party Committee and Executive Vice President of Huazhong University of Science and Technology, as well as the Party Secretary of Tongji Hospital, in collaboration with Professor Luo Xiang from the Department of Neurology and Professor Zhang Huaqiu from the Department of Neurosurgery. By integrating the superior clinical resources of the neurology and neurosurgery departments at Tongji Hospital, along with the hospital’s rigorous clinical trial system and extensive experience, the study aims to investigate the safety, tolerability, and efficacy of bilateral intracerebral targeted injection and transplantation of dopaminergic precursor cells for the treatment of early-onset Parkinson's disease. Previously, in December 2023, Wuhan iRegene Therapeutics Co., Ltd. (iRegene) received approval from the National Medical Products Administration (NMPA) to advance its globally innovative dopaminergic precursor cell product for early-onset Parkinson's disease into the registration clinical trial phase. This marks China's first dopaminergic precursor cell therapy product for early-onset Parkinson's disease to enter the registration clinical trial stage.

Currently, in the ongoing registrational clinical trial for idiopathic Parkinson's disease conducted by iRegene, all participants in the low-dose group have completed enrollment and dosing, and the sentinel trial for the high dose has been successfully carried out, verifying the safety of surgical administration at a high dose. Based on the data from multiple subjects across both low- and high-dose groups, the injection of dopaminergic precursor cells demonstrated good safety, while significant improvement in motor symptoms was observed, with a marked reduction in UPDRS motor scores. More importantly, PET imaging confirmed a substantial enhancement in the dopamine secretion and transport function of the transplanted cells within the subjects, providing preliminary evidence of the cells' activity in vivo. The experience and data gathered from this idiopathic Parkinson’s disease clinical trial provide a solid foundation for the upcoming trial targeting early-onset Parkinson’s disease.

The teams participating in this clinical trial initiation meeting include Professor Wang Wei, Professor Luo Xiang, Professor Zhang Huaqiu, Associate Chief Physician Qin Chuan, Associate Chief Nurse Chen Daiqi from Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Dr. Cai Meng (CMO) , Dr. Wei Jun (CEO), Dr. Yan Ruorong (R&D Vice President) from iRegene, as well as the CRO and SMO project teams, among others.

At the launch meeting, the attending representatives conducted extensive discussions on the implementation of the clinical trial protocol from multiple dimensions, including strategy for protocol implementation, operational details, contingency plans for potential risks, and more. Among them, Professors Wang Wei, Zhang Huaqiu, and Luo Xiang provided valuable suggestions on key aspects of the project based on the characteristics of the research center. They emphasized the principle of prioritizing patient benefits and the importance of multidisciplinary collaboration, offering valuable insights and recommendations for the smooth progress of this study. Under the leadership of Professors Wang Wei, Luo Xiang, Zhang Huaqiu, and the leading departments of Tongji Hospital affiliated with Huazhong University of Science and Technology, the clinical research team will engage in the clinical trial with a rigorous attitude, striving to provide a novel treatment option for patients with early-onset Parkinson's disease.

NouvNeu003 Injection, fully independently developed by Wuhan iRegene (a Class I biological product), is also the world’s first universal cell therapy product based on chemical induction to enter the new drug registration clinical stage in the field of early-onset Parkinson's disease treatment. As one of the earliest biotech companies globally to apply "AI + chemical induction" to the specific functional modification of cells, iRegene has established a rich pipeline of universal iPSC products on this unique platform. It aims to develop universal cell therapy products and provide new treatment options for currently "incurable" diseases such as neurodegenerative disorders represented by Parkinson's disease and blindness.

Source: iRegene