iRegene Therapeutics announced promising NouvNeu001 Phase I clinical data

CHENGDU, China, Oct. 13, 2025 /PRNewswire/ -- iRegene Therapeutics Co., Ltd. ("iRegene" or the "Company") is recognized as a biotechnology company pioneering chemically induced allogeneic cell therapy. iRegene's lead product, NouvNeu001, is the 1st iPSC therapy to receive IND approval from both the NMPA and the FDA to treat Parkinson's disease (PD). Recently, NouvNeu001 Phase I clinical data were presented at the International Congress of Parkinson's Disease and Movement Disorders (MDS).

Excellent safety and tolerability were observed for up to 15 months post-transplantation, notably without the use of immunosuppressants after the sixth month. NouvNeu001 was administered via a stereotactically guided procedure, with bilateral injections into the posterior putamen through a single injection trajectory per hemisphere. PET imaging confirmed the long-term engraftment, survival and maturation of the transplanted cells. Significant clinical efficacy was observed, including marked improvements in MDS-UPDRS Part III motor scores. In the low-dose cohort, UPDRS-III scores improved by an average of 30.6 points in the OFF state (a 52.82% improvement from baseline) and 12.9 points in the ON state (a 54.67% improvement from baseline）at 12 months post-transplantation. Similarly, in the high-dose cohort, scores decreased by an average of 23.3 points (OFF) and 9.67 points (ON) at 9 months post-transplantation. These improvements were statistically significant, with continued improvement observed through 15 months post-treatment.

Dr. Meng Cai, Chief Medical Officer of iRegene Therapeutics, explained why the Phase I results of NouvNeu001 are so promising. He stated:

"The encouraging outcomes from the Phase I trial of NouvNeu001 can be attributed to iRegene's unique chemical induction platform and optimized clinical strategies. iRegene uses a proprietary chemical inducer cocktail to generate high-purity A9 dopaminergic progenitor cells with enhanced functionality. In addition, the surgical procedure was specifically designed to utilize a single injection trajectory per hemisphere, significantly reducing potential surgical risks and related adverse events."

Dr. Jun Wei, Chief Executive Officer of iRegene Therapeutics, added:

"The iRegene team is greatly encouraged by this important milestone. We remain fully committed to advancing the completion of the Phase II clinical trial and the international multi-center Phase I clinical trial，and achieving the next milestones in our mission to bring transformative therapies to patients with Parkinson's disease."

About NouvNeu001

iRegene's flagship product, NouvNeu001, is the world's first clinical-stage, iPSC-derived, allogeneic dopaminergic progenitor cell therapy for PD. NouvNeu001 received the China NMPA's IND clearance to initiate Phase I/II in China on Aug 2023, and received the FDA IND clearance to initiate Phase I in USA on June 2024. In April 2025, iRegene launched a multicenter Phase II clinical trial in China (NCT06167681).

On August 15, 2025, NouvNeu001 was granted Fast Track Designation (FTD) from the U.S. FDA, becoming the first allogeneic iPSC-derived PD cell therapy worldwide to earn this recognition. This milestone follows the FDA's Special Exemption (SE) granted in March 2024, further validating iRegene's clinical data integrity, product quality system, and innovative therapeutic approach.

About iRegene Therapeutics

Founded in 2017 by a team of international professionals, iRegene Therapeutics is the earliest biotech in the world to apply " Chemical induction" to precisely reprogram cell fate and optimize cellular functions. Leveraging this breakthrough platform, iRegene Therapeutics has built a robust pipeline targeting currently "incurable" diseases such as Parkinson's disease and blindness. As a leader in chemical induction, iRegene's proprietary system enables the efficient easy generation of human specific cell types with high purity, and enhanced cellular functionality, pioneering the next generation of chemically derived cell therapies.

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SOURCE iRegene therapeutics