Ruijian Medicine Completes Full Enrollment in Phase I Clinical Trial of NouvNeu001, a Universal iPSC-Derived Cell Therapy for Mid-to-Late Stage Parkinson’s Disease

Recently, iRegene Therapeutics Co., Ltd. (iRegene) completed the dosing of the last participant in the high-dose group for the Phase I clinical study of its self-developed product NouvNeu001 injection for mid-to-late stage Parkinson's disease at Beijing Hospital. So far, the NouvNeu001 study has successfully completed the dosing of all participants as planned, with good observed safety and tolerability, achieving the primary objectives of the study. iRegene is not only the world's only cell therapy company to receive FDA "special exemption" status, but also a globally 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 in the number, quality, and progress of clinical trials.

Current results show that: The overall safety of the low-dose group participants is good, with no cell drug-related AE or SAE reactions. Participants exhibited 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, verifying the healthy survival of NouvNeu001, a universal cell therapy product, in patients post-transplantation. Additionally, data from the sleep PSQI and quality of life PDQ39 assessments indicate improvements in non-motor symptoms among participants. After completing dosing in the low-dose group and undergoing a detailed safety evaluation by an expert panel, iRegene initiated enrollment for the high-dose group, which has shown good safety and similarly demonstrates an improving trend in motor function with increased transplantation time. 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.

The successful completion of the Phase I enrollment for the NouvNeu001 project marks an important milestone, signifying that iRegene has reached a new stage in clinical development. The Phase II clinical trial is expected to initiate enrollment in Q1 2025. iRegene will continue to accelerate the research process and work towards transforming this innovative achievement into a clinically available treatment option as soon as possible.

Dr. Cai Meng, CMO of iRegene, stated that the successful completion of patient enrollment in the Phase I clinical trial of NouvNeu001 reflects the ambitious spirit of iRegene's young team. We sincerely thank the expert teams at all clinical research centers involved in the NouvNeu001 project for their strong support and the trust of the participants. We also appreciate the dedicated collaboration of both the iRegene team and external partners! We will continue our efforts to accelerate the development of this product. The company will also fully advance its subsequent clinical pipeline with the aim of benefiting more patients worldwide as soon as possible.