SEOUL, South Korea, May 1, 2025 — S&E bio, a biotech firm focused on therapies utilizing exosomal microRNA, has secured approval from the Korean Ministry of Food and Drug Safety (MFDS) to commence a Phase 1b clinical study for their stroke treatment candidate, SNE-101. This marks the first exosome-based therapy in Korea to progress to clinical trials, representing a significant achievement for the nation’s biopharmaceutical sector.

S&E bio’s SNE-101 was created using a unique 3D culture system that enhances exosome production from mesenchymal stem cells derived from umbilical cords. These exosomes contain therapeutic microRNAs designed to promote neuroregeneration.

The approval was granted after successful resolution of Chemistry, Manufacturing, and Controls (CMC) concerns, along with demonstrated therapeutic effectiveness in both rodent and non-human primate models, the latter providing a more accurate representation of human stroke pathology. Long-term safety has also been established.

The Phase 1b trial will assess the safety, dose-limiting toxicity, and early-stage efficacy of SNE-101 when administered intravenously. Given the absence of approved pharmacological treatments beyond reperfusion for stroke, SNE-101’s potential to provide neuroregenerative, neuroprotective, and anti-inflammatory benefits offers a promising avenue for enhancing stroke patient recovery.

Media Contact:

Jae Bok Ban
COO, Business Development Division, S&E bio
 

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