iRegene Therapeutics Gains U.S. and China Clearance for Retinitis Clinical Trials
iRegene Therapeutics' cell therapy NouvSight001 has received regulatory clearance in both the U.S. and China to proceed with clinical trials. The treatment targets retinitis pigmentosa.
Biotechnology company iRegene Therapeutics has secured regulatory clearance from the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA) to commence clinical trials for its regenerative cell therapy, NouvSight001. The therapy is intended for patients suffering from retinitis pigmentosa (RP).
NouvSight001 is an allogeneic, off-the-shelf photoreceptor cell therapy developed using iRegene's proprietary AI + Chem platform. This technology aims to make cell differentiation processes more predictable and scalable, crucial for the industrial manufacturing of the therapy. The treatment is designed to replace damaged retinal cells.
In the U.S., a Phase I/II trial will commence, while a Phase I/III trial will launch in China. Both studies will evaluate the therapy's safety, tolerability, and preliminary efficacy. The FDA has also granted a special exemption for the treatment. Retinitis pigmentosa is a group of inherited retinal degenerative diseases affecting an estimated 1.5 million people worldwide.
The clearances mark a significant advancement for iRegene's global development model, where a single technology platform facilitates the development and international rollout of multiple therapies targeting diverse cell types and diseases. The company is focusing on developing treatments for age-related conditions.