RJ Medicine Announces Phase II Clinical Trial Initiation of NouvNeu001, the World’s First Chemically Induced, iPSC-Derived Allogeneic Cell Therapy for Parkinson’s Disease

Apr 07, 2025 08:30 CST Updated 08:30

iRegene Therapeutics

Cell Therapy Product Developer

Recently, iRegene Therapeutics Co., Ltd. (iRegene) successfully heldThe Phase II Clinical Trial Kick-off Meeting of NouvNeu001.This is another milestone event announced by iRegene after it pioneered the world's first universal iPSC-derived cell therapy product to enter the clinical stage in the field of Parkinson's disease.

On August 2, 2023, the National Medical Products Administration (NMPA) officially approved the Phase I/II clinical study evaluating the safety, tolerability, and efficacy of NouvNeu001 in treating mid-to-late stage Parkinson's disease. This is a multicenter, open-label designed study. NouvNeu001 is the world’s first universal cell therapy product based on iPSC and chemically induced technology to enter the new drug registration clinical stage in the field of Parkinson's disease treatment.

In November 2024, the company announced,The Phase I clinical trial of NouvNeu001 injection for mid-to-late stage Parkinson's disease has successfully completed the dosing of all planned participants. Clinical data indicates that it demonstrates good safety and tolerability, achieving the primary objectives of the study.

iRegene is not only the world's only cell therapy company to receive the FDA "Special Exemption" qualification, but also 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.NouvNeu001 Clinical Trial Results Show: The overall safety of the low-dose group participants was good, with no cell drug-related AE or SAE reactions. Participants showed an average improvement of over 20 points in the UPDRS III motor function section six months after transplantation, along with positive effects such as reduced dyskinesia and extended "on" periods. PET imaging analysis also confirmed a significant increase in dopamine transporter activity in the transplant area over time, demonstrating the healthy survival of NouvNeu001, a universal cell therapy product, in patients after transplantation. Additionally, data from sleep PSQI and quality of life PDQ39 assessments indicated improvements in non-motor symptoms among participants. After completing dosing in the low-dose group and a detailed safety evaluation by an expert panel, the high-dose group enrollment was initiated. The high-dose group also demonstrated good safety and a similar trend of motor function improvement over time post-transplantation. The interim results of NouvNeu001 preliminarily confirm the therapeutic effect of chemically induced functional dopamine precursor cell products on mid-to-late stage Parkinson's disease.

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