Ruijian Medicine Successfully Launches Clinical Trials of NouvSoma001 for NMOSD and Ischemic Stroke

Wuhan iRegene Pharmaceutical Technology Co., Ltd. collaborates with Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, to initiate the clinical research of NouvSoma001, an extracellular vesicle product derived from chemically induced cells.

This clinical trial focuses on Neuromyelitis Optica Spectrum Disorder (NMOSD), an immune-mediated inflammatory demyelinating disease of the central nervous system. As the patient's immune system attacks the optic nerve and spinal cord, NMOSD is clinically characterized by optic neuritis, longitudinally extensive transverse myelitis, area postrema syndrome, brainstem syndrome, diencephalic syndrome, and cerebral syndrome, ultimately leading to vision loss and paralysis. Although NMOSD can be treated with corticosteroids (e.g., methylprednisolone) and immunosuppressive drugs, there is currently no cure. This project utilizes NouvSoma001, a chemically induced cell-derived extracellular vesicle product, for the treatment of NMOSD, representing an active exploration into a novel therapy for this immune-mediated inflammatory demyelinating disease of the central nervous system.

Also launched simultaneously this time is the "Exploratory Clinical Study Evaluating the Safety and Efficacy of NouvSoma001 Injection in the Treatment of Ischemic Stroke" conducted by the same research team. This project involves an open-label, placebo-controlled, single-center clinical study on ischemic stroke patients receiving intravenous injections to evaluate safety, tolerability, and efficacy respectively. Ischemic stroke refers to acute neurological deficits caused by localized cerebral ischemia and permanent cerebral infarction (e.g., positive findings on DWI examination).

NouvSoma001 Injection is a product independently developed by the company using its existing mature technology platform. It is a chemically induced extracellular vesicle-based product. Preclinical studies have preliminarily demonstrated the safety and efficacy of this product in primate models, laying the foundation for clinical application and supporting its clinical feasibility. (Source: Wuhan iRegene Therapeutics Co., Ltd.)