S&E bio Co Ltd, a South Korea-based biotechnology company specialising in exosomal microRNA-based therapies, announced on Thursday that it has received approval from Korea's Ministry of Food and Drug Safety (MFDS) to initiate a Phase 1b clinical trial of its investigational stroke therapy, SNE-101.

This is the first exosome-based therapy in Korea to enter clinical trials.

S&E bio developed SNE-101 using a proprietary 3D culture system to optimise exosome production from umbilical cord-derived mesenchymal stem cells. The exosomes carry therapeutic microRNAs designed to enhance neuroregeneration.

MFDS approval followed successful resolution of Chemistry, Manufacturing and Controls (CMC) issues, as well as demonstration of therapeutic efficacy, not only in rodent models, but also in non-human primates, which better reflect human stroke pathology. Long-term safety was also confirmed.

The Phase 1b trial will evaluate the safety, dose-limiting toxicity and preliminary efficacy of SNE-101 via intravenous administration.