It is reported that the multicenter, open-label clinical trial (Phase I/II) is meticulously crafted to systematically evaluate the safety, tolerability, and efficacy of stereotactic bilateral intracerebral injection of NouvNeu001 for treating moderate to advanced Parkinson's disease. So far, the Phase I clinical trial has been successfully initiated at both Beijing Hospital (Beijing, PRC) and Zhongnan Hospital (Wuhan, PRC), with dosing completed for its first patient.

Dr. Cai, CMO of iRegene, said that the completion of the first patient dosing and the successful observation period marks an important milestone in the development of iRegene Therapeutics.

Publicly available information reveals that the NouvNeu001 is a chemically induced human dopaminergic neuron precursor from iPSC, with iRegene Therapeutics wholly owned proprietary. NouvNeu001 is the world's first iPSC-based and chemically induced universal cell therapy product. This product attains high-purity reconstruction and functional optimization of neuronal subtypes via chemical induction. Upon transplantation, it establishes connections with the body's existing neurons and augments cellular secretion functions, thereby reinforcing the transplanted cells' ability to improve the original lesion. In this way, it can provide comprehensive therapeutic effects.

On August 2, 2023, the National Medical Products Administration (NMPA) of China officially approved the Phase I/II clinical trial of NouvNeu001, designed to assess the safety, tolerability and efficacy in treating moderate to advanced Parkinson's disease. The clinical trial commenced successfully in early January 2024 at Beijing Hospital. More information about this trial is available at clinicaltrials.gov (NCT#06167681).

iRegene Therapeutics, the pioneering biotech company behind NouvNeu001, stands as one of the global frontrunners in harnessing "AI + chemical induction" for cell-specific functional remodeling. Leveraging its unique "AI + chemical induction" platform, iRegene Therapeutics has developed an extensive pipeline of universal iPSC-derived products. The company is dedicated to advancing universal cell therapy products and introducing novel treatment alternatives for traditionally "incurable" neurodegenerative diseases, including Parkinson's disease and blindness.