The first exosome-based clinical trial begins in Korea. This marks the first time the Korean Ministry of Food and Drug Safety has approved an exosome therapy clinical trial.

S&E Bio announced on the 17th that it has received approval from the Ministry of Food and Drug Safety for the clinical trial plan of its exosome-based acute stroke treatment, 'SNE-101,' for Phase 1b.

Exosomes are nanoscale particles secreted by cells that play a role in intercellular communication, regeneration, immune regulation, and anti-inflammatory processes, attracting attention as a new modality for drug development. However, for years, the KFDA has rejected clinical requests from companies due to challenges in standardizing the production and quality management systems (CMC).

As a result, domestic exosome therapy development companies have faced difficulties in conducting clinical trials in Korea. Companies like Brexogen turned to the United States, while another company, Ilios Bio, sought trials in Australia. Overseas trials are costly, and domestic patients find it hard to benefit.

S&E Bio has become the first case to obtain clinical approval while meeting domestic regulatory standards. After first knocking on the KFDA's door in 2023, the approval has come in just over two years.

SNE-101 is an acute stroke treatment based on exosomes derived from umbilical cord-derived stem cells. S&E Bio has utilized its own 3D cell culture technology to precisely control the cellular microenvironment, resulting in the production of exosomes that are rich in microRNAs related to neural regeneration.

SNE-101 has shown significant recovery in the most common and serious post-stroke complication, 'loss of hand function,' in experiments that applied treatment after inducing acute stroke in primates. Additionally, the restructuring and recovery of neural circuits were also confirmed.

This clinical trial aims to evaluate the dose-limiting toxicity (DLT), safety, and preliminary efficacy of SNE-101 through intravenous administration to acute stroke patients. SNE-101 targets multiple mechanisms simultaneously, including neurovascular reformation, antioxidant effects, and inflammation suppression.