First Patient Dosed in Multi-Center Clinical Trial of Ruijian Medicine's Novel Parkinson’s Therapy NouvNeu001

Feb 05, 2024 12:28 CST Updated 12:28

iRegene Therapeutics

Cell Therapy Product Developer

Recently, Wuhan iRegene Therapeutics Co., Ltd. (iRegene) announced that the first patient has been dosed with its first globally innovative product, NouvNeu001, at Beijing Hospital, and has successfully passed the observation period.

It is reported that this study is a multi-center, open-label designed Phase I/II clinical trial, aiming to systematically evaluate the safety, tolerability, and efficacy of stereotactic bilateral intracerebral injection of NouvNeu001 in treating mid-to-late stage Parkinson's disease. Currently, the Phase I clinical trial has been successfully initiated at Beijing Hospital and Zhongnan Hospital of Wuhan University, with the first patient dosing completed.

Dr. Cai Meng, CMO of iRegeneThe completion of dosing for the first patient and the smooth observation period marks an important milestone in the development process of iRegene.

Public information shows that NouvNeu001 injection, fully independently developed by Wuhan iRegene (Class I biological product), is a chemically induced human dopaminergic neuronal precursor.It is also the world's first universal cell therapy product based on iPSC and chemical induction to enter the new drug registration clinical stage in the field of Parkinson's disease treatment.The product achieves high-purity neuronal subtype reconstruction and functional optimization through chemical induction. After transplantation, it forms connections with the body's original neurons, enhances cellular secretion functions, and further strengthens the improvement of the original lesion by the transplanted cells, achieving a comprehensive therapeutic effect.

On August 2, 2023, the National Medical Products Administration (NMPA) officially approved the Phase I/II clinical study of NouvNeu001 for the safety, tolerability, and efficacy in treating mid-to-late stage Parkinson's disease. The clinical trial was successfully initiated at Beijing Hospital, the leading institution, in early January 2024.

iRegene, which independently developed NouvNeu001, is one of the earliest Biotech companies globally to apply "AI + chemical induction" to the specific functional modification of cells.Based on the unique platform of "AI + chemical induction," iRegene has established a rich pipeline of universal iPSC products., aiming to develop universal cell therapy products for "incurable" diseases such as neurodegenerative diseases represented by Parkinson's disease and blindness, and provide new treatment options.

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