Pharma Focus America

Iregene Receives FDA Approval to Begin Clinical Trial Targeting Parkinson's Disease

Tuesday, June 25, 2024

The U.S. Food and Drug Administration (FDA) recently approved iRegene Therapeutics' IND application for NouvNeu001, a novel cell therapy aimed at treating Parkinson's Disease. This development marks a significant achievement, as NouvNeu001 becomes the first chemically induced allogeneic cell therapy to advance to clinical stages for Parkinson's in the U.S. Prior to this, NouvNeu001 had already gained approval from China's NMPA in August 2023 for a Combined Phase I/II Clinical Study, where it showed positive safety and efficacy results during Phase I trials. On June 20, 2024, iRegene announced the FDA's IND approval for NouvNeu001 specifically for treating mid-to-late stage Parkinson's disease.

In March 2024, iRegene also secured an exemption from the FDA, underscoring recognition of its innovative platform and production systems. Dr. Cai Meng, iRegene's CMO, emphasized that this exemption, along with the IND approval for NouvNeu001, highlights iRegene's expertise in developing its chemically induced platform. These milestones also pave the way for iRegene to expand its operations internationally.

iRegene is a pioneer in utilizing "AI + chemical induction" to modify cell functions, offering advantages in efficiency, safety, cost-effectiveness, and scalability. Leveraging this platform, iRegene has developed a robust pipeline of iPSC-derived cell products targeting "incurable" diseases such as Parkinson's and blindness.

Clinical trials for NouvNeu001 commenced successfully in early 2024 at Beijing Hospital and Zhongnan Hospital of Wuhan University in China. These trials aim to evaluate the safety, tolerability, and efficacy of NouvNeu001 in mid-to-late stage Parkinson's disease through stereotactic bilateral intracerebral injections. Preliminary results indicate significant improvements in motor scores and a favorable safety profile among patients receiving NouvNeu001.

Moving forward, iRegene plans to initiate clinical trials for NouvNeu003, its product for early-onset Parkinson's disease, which received approval from China NMPA in December 2023.

Beyond neurodegenerative diseases, iRegene is exploring treatments for other "incurable" conditions. In March of this year, the FDA granted Orphan Drug Designation to iRegene's NouvSight001, an iPSC-derived ophthalmic allogeneic cell therapy targeting retinal diseases.

Dr. Wei Jun, CEO of iRegene, highlighted the team's commitment to rigorous standards and steady R&D progress, aiming to bring groundbreaking therapies to patients affected by currently untreatable diseases globally.



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