iRegene Therapeutics Presents Groundbreaking Phase I Data of NouvNeu001, the World’s First Chemically Induced Allogeneic Dopaminergic Neural Progenitor Cell Therapy for Moderate-to-Severe Parkinson’s Disease, at MDS Congress 2025

On October 6, 2025, iRegene Therapeutics, a global leader in innovative off-the-shelf cell therapy utilizing chemically induced pluripotent stem cells (iPSC), was invited to deliver an oral presentation at the highly anticipated 2025 International Parkinson and Movement Disorder Society Congress (MDS Congress). The presentation focused on the groundbreaking research of NouvNeu001, the world’s first chemically induced universal dopaminergic neural progenitor cell therapy derived from iPSC for the treatment of moderate to severe Parkinson's disease. The unique chemically induced platform and its significant Phase I clinical trial data, which highlight its distinct advantages, garnered substantial attention from numerous clinical experts, investment firms, international pharmaceutical giants, and research institutions attending the conference. More importantly, iRegene's NouvNeu001 being selected as the opening report in the clinical trials session of the International Parkinson and Movement Disorder Congress not only reflects the recognition of iRegene’s work by the International Parkinson and Movement Disorder Society but also underscores the attention and encouragement from international professional bodies towards iRegene’s pioneering efforts in the field of Parkinson's disease treatment.

iRegene CEO Dr. Wei Jun, on behalf of the iRegene team and the clinical trial team, presented the unique advantages of iRegene's chemical induction platform at the conference. The significant breakthrough data from Phase I clinical trials of NouvNeu001 originated from iRegene's proprietary chemical induction platform and optimized clinical strategy. iRegene utilized its proprietary chemical induction system to obtain groundbreaking high-purity, functionally enhanced dopaminergic subtype precursor cells from iPSCs. For the first time internationally, iRegene adopted a "patient benefit prioritized" single-needle stereotactic drug delivery method, significantly reducing surgical risks and related adverse events.

The chemical induction platform has demonstrated significant advantages not only in preclinical research but also further validated its therapeutic benefits in Phase I clinical trials: iRegene's chemical induction platform has safely optimized the immunogenicity of universal cell products. As a result, patients did not experience immune rejection or related adverse events after discontinuing immunosuppressants six months post-surgery. Additionally, mature neuron PET imaging results at the large cohort level further confirmed the excellent long-term survival and stable differentiation and integration capabilities of NouvNeu001 in the brains of Phase I trial participants.

More importantly, iRegene's chemical induction platform has achieved targeted modification and enhancement of the therapeutic functions of dopamine neurons. As a result, the MDS-UPDRS Part III scores (motor function scores) of NouvNeu001 subjects showed significant improvement after transplantation: 12 months post-administration, the UPDRS-III scores improved by an average of 30.6 points in the OFF state (an average improvement of 52.82% from baseline) and by an average of 12.9 points in the ON state (an average improvement of 54.67% from baseline). The improvements in multiple indicators were statistically significant, surpassing international competitors and other treatment options, with sustained improvement effects observed even 15 months later. Additionally, several non-motor symptoms, such as standardized Good ON Time, also showed significant improvement after treatment. The statistically significant Phase I clinical data further confirm the unique technical advantages of iRegene's pioneering chemical induction platform.

Notably, as a special session for pharmaceutical companies' clinical trial reports, the presentations on clinical progress alongside iRegene included innovative products from heavyweight international pharmaceutical giants in the Parkinson’s disease new drug development field, such as BlueRock, Roche, and Biogen. This represents the strongest lineup in the Parkinson’s disease new drug research and development arena. Dr. Meng Cai, Chief Medical Officer of iRegene, also attended the conference同期参会), discussing multiple topics related to clinical trials for Parkinson's disease new drug development with numerous international experts. They reviewed the latest advancements and future R&D strategies of well-known pharmaceutical companies in China and abroad regarding disease-modifying therapies for Parkinson’s disease. Dr. Cai also stated, "Exchanging ideas on several core topics in cell therapy clinical trials for Parkinson's disease with many international peers has been highly beneficial and acknowledged by our global counterparts. This marks an important milestone for iRegene in advancing international industry progress. International peers and clinical principal investigators (PIs) are very much looking forward to the clinical performance of NouvNeu001 overseas. We will continue to accelerate the completion of Phase II clinical trials and the international multicenter Phase I clinical trial of NouvNeu001, steadfastly committed to bringing breakthrough therapies to patients with Parkinson’s disease."

References:

1.https://mp.weixin.qq.com/s/IM-C5L_ills4cpchIq9jmw

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