Ruijian Medicine Completes Phase I Enrollment of NouvNeu003, the World’s First iPSC-Derived Cell Therapy for Early-Onset Parkinson’s Disease

Mar 07, 2025 07:21 CST Updated 07:21

iRegene Therapeutics

Cell Therapy Product Developer

March 7, 2025

eMedClub News

Recently,iRegene announced that its self-developed innovative drug NouvNeu003 injection for the treatment of early-onset Parkinson's disease has been actively advanced under the collaboration with Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.Completion of Enrollment for All Subjects in Phase I Clinical Trial。

This isThe world's first multi-target drug for early-onset Parkinson's disease to enter the registration clinical stageDopaminergic Precursor Cell Therapy ProductThe successful completion of the Phase I enrollment for the NouvNeu003 project marks a significant milestone in the drug's development, representing a crucial step forward in the advancement of the Parkinson's disease pipeline.

▲ Image Source:iRegene

Unlike common Parkinson's disease, early-onset Parkinson's disease is characterized by its onsetEarly age of onset, long disease duration, and high heterogeneity in clinical manifestations, a more difficult-to-treat type of Parkinson's disease. The Phase I clinical trial was led by Professors Wang Wei, Luo Xiang, and Zhang Huaqiu from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. The team advanced scientifically and rigorously, focusing on safety verification, aiming to evaluate the safety and tolerability of the drug in patients with early-onset Parkinson's disease, and based on this, explore the cellular treatment patterns of NouvNeu003 in the early-onset Parkinson's disease population.

The trial is currently proceeding smoothly, with subjects showing good tolerance to the drug and no serious adverse reactions reported. The initial data aligns with expectations and has preliminarily uncovered unique cellular treatment 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 pioneeringly obtain the FDA "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: "As a rare neurodegenerative disease, early-onset Parkinson's disease affects patients at a younger age with a faster progression, necessitating greater societal attention and safer, long-acting treatment options. The smooth progress of this Phase I trial highlights the profound expertise of the iRegene team and Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology in the field of neurological disorders. We would like to extend special thanks to all participants in the clinical trial for their contributions to our work. Moving forward, we will accelerate clinical research to bring breakthrough therapies to patients as soon as possible. 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 also maintain close communication with regulatory agencies, clinical experts, and patient organizations to ensure the drug benefits patients worldwide at the earliest opportunity."

Last yearNovember,iRegeneiRegene's NouvNeu001 Injection Completes Dosing of the Last Subject in the High-Dose Group for Phase I Clinical Study on Mid-to-Late Stage Parkinson’s Disease at Beijing Hospital. This also meansNouvNeu001 Study Has Completed Enrollment and Dosing of All Participants as Planned.

The results showed that:The overall safety of the low-dose group was good, with no cell drug-related AE or SAE reactions. Furthermore, six months after transplantation, subjects showed an average stable improvement of over 20 points in the UPDRS III motor function section. Additionally, positive effects such as reduced dyskinesia and extended "on" periods were observed. These results preliminarily demonstrateNouvNeu001 has therapeuticThe Potential of Mid-to-Late Stage Parkinson's Disease.

Currently,iRegeneiRegeneMedicine in ChinaMany advances have been made in the field of Parkinson's disease, and we look forward to more treatment options for patients in the future.

References:

1. iRegene Official Website

Welcome to register for the 2026 IBI EXPO conference.

Registration and Event Inquiry

IBI EXPO 2026 (4th) Biopharmaceutical Innovation Industry ConferenceWill beMarch 2026InHangzhouGrandly Held.The conference will invite300+Guest Speaker, iRegene30+Venue Forum Activities, LinkagePharmaceutical companies, research institutions, clinical resources, supply chain enterprises, investment and financing institutions, park governmentsThrough the efforts of multiple parties, cutting-edge innovations are being transformed from scientific research to industrial applications, injecting a source of development into the biopharmaceuticals market.

Free Participation:Teacher Yang 15517201185

Free Exhibition:Teacher Yuan 15572286596

Speech & Media：Teacher Wang 18717836231

Click"Read the original text"Lock in Early Bird Discounts

Statement and Copyright Notice

Disclaimer: This article aims to convey industry development information and explore the frontier progress of biomedicine. The content of the article represents the author's viewpoint, and does not represent the position of EBC, nor does it constitute any value judgment, investment advice, or medical guidance. If necessary, please consult a professional for investment or visit a regular hospital for medical advice.

Copyright Statement:Welcome to share the article on your personal WeChat Moments. Unauthorized reprinting by media or organizations in any form to other platforms is prohibited. If you need to reprint, please leave a message below the article to obtain authorization.

DianDian "Share”、“Like" and "In View"，Give me a little charge~