iRegene Bags IND Approval from US FDA To begin Clinical Trial

iRegene Therapeutics, an earliest biotech firm in the world focusing on correctly reprograming cell destiny and functions utilizing chemicals, On June 20, the US Food and Drug Administration (FDA) approved the IND application for NouvNeu001, a cell therapy product developed by the business to treat Parkinson's disease. This is a significant milestone because NouvNeu001 is the first chemically induced allogeneic cell therapy product to begin clinical trials for Parkinson's disease in the United States. 

Previously, the "Combined phase I/II Clinical Study" of NouvNeu001 was approved by China's NMPA in August 2023 after demonstrating positive safety and efficacy evidence in phase I trials. On June 20, 2024, iRegene reported that NouvNeu001 had received IND approval from the US FDA for the treatment of Parkinson's disease in the mid- to late stages. Notably, in March 2024, iRegene received an exemption from the FDA, demonstrating the FDA's acceptance of iRegene's pioneering platform and unique manufacturing and quality methods.

Dr. Cai Meng, CMO of iRegene, stated that gaining the FDA exemption, followed by the IND approval for NouvNeu001, demonstrates iRegene's skill in building unique chemically induction platforms. This milestone opens the stage for iRegene's future worldwide activities.

Following significant progress in the NouvNeu001 clinical trial and preliminary positive efficacy and safety data, iRegene will soon begin patient recruitment for the clinical trial of its early-onset Parkinson's disease product, NouvNeu003, which was also approved by the China NMPA in December 2023.