Hengyu Bio Congratulates iRegene on FDA IND Approval for NouvNeu001 to Initiate Overseas Clinical Trials
iRegene Therapeutics
Cell Therapy Product Developer
On June 24, iRegene announced that the U.S. FDA had officially approved itsParkinson's Pipeline NouvNeu001The IND application.In the field of Parkinson's,The World's First Chemically Induced Universal Cell Therapy Product to Enter Clinical StageNouvNeu001 "Phase I-II Combined Clinical" study was approved by the National Medical Products Administration (NMPA) in August 2023 and has achieved positive safety and efficacy data in Phase I clinical trials. On June 20, 2024, iRegene also achieved "dual filing and dual approval" for its Parkinson's pipeline in both China and the United States.Notably, the FDA granted iRegene's groundbreaking product a Special Exemption in March 2024.
In response,Dr. Meng Cai, Chief Medical Officer (CMO) of iRegeneIt indicates that after obtaining the FDA special exemption, NouvNeu001 IND has been further approved by the FDA, demonstrating the FDA's high recognition of iRegene's pioneering chemical induction platform and its innovative products.
Public information shows that iRegene is one of the companies globally that has applied "AI + chemical induction" to the specific functional modification of cells.The platform has the advantages of being more efficient, safer, lower-cost, and more suitable for large-scale industrial production in terms of cell function modification. Based on this platform,iRegene has establishedRich General-purpose Induced Pluripotent Stem Cells (iPSC)Product Pipeline: Developing universal cell therapy products for "incurable" diseases such as neurodegenerative disorders represented by Parkinson's disease and blindness.Bring Possible Cures.
NouvNeu001 is a universal cell therapy product based on chemical induction., which achieves high-purity neuronal subtype reconstruction and functional optimization through compound regulation, forms connections with the original neurons in the body, and enhances cellular secretion functions, further strengthening the improvement of the original lesion by the transplanted cells to achieve a comprehensive therapeutic effect.
At the beginning of 2024, NouvNeu001 has successfully initiated clinical trials at Beijing Hospital and Zhongnan Hospital of Wuhan University. By integrating the advantageous clinical resources of neurosurgery, neurology, and other departments, researchers will systematically evaluate the safety, tolerability, and efficacy of stereotactic bilateral intracerebral injection of NouvNeu001 in treating mid-to-late stage Parkinson's disease. Currently, this clinical project has entered an accelerated phase. According to the results of multiple clinical cases independently completed at multiple centers, treatment with NouvNeu001 not only achieved rapid and significant improvement in MDS-UPDRS scores but also greatly enhanced patients' quality of life, with good safety and no related adverse reactions. The NouvNeu001 project is about to enter the dose expansion phase.
In the field of neurodegenerative diseases, iRegene has also developed another research product, NouvNeu003. In December 2023,NouvNeu003 has been approved by the NMPA to conduct clinical trials, targeting indications primarily for early-onset Parkinson's patients with an onset age of less than 50.According to the news release from iRegene, the company will also initiate patient recruitment for the NouvNeu003 clinical trial in the near future.
Beyond neurodegenerative diseases, iRegene continues to explore other "incurable" disease areas. In March this year, the company's breakthrough ophthalmology product NouvSight001 received orphan drug designation from the U.S. FDA. This product is the first developed by iRegene.iPSC-Derived Universal Cell Therapy Products for Ophthalmology, intended for development to treat "a series of indications related to retinitis pigmentosa".
Dr. Wei Jun, CEO of iRegene, stated: "In the field of iPSC innovative therapies, iRegene has maintained a high level of rigor while balancing the pace of research and development. The project advancement plans previously established by the company were meticulously timed down to the ‘week’, which laid an essential foundation for the company to continuously push its core pipelines into clinical trials as scheduled. On the basis of prudent and steady R&D, iRegene hopes to leverage its cutting-edge technology to bring breakthroughs to a large number of currently incurable diseases, creating hope for patients and families suffering from related conditions. The recent achievement of 'dual filing and dual approval' in both China and the U.S. for NouvNeu001 has further strengthened the confidence of iRegene's international team in building a world-class innovation platform."
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