S&E bio Receives Korea's First Approval for Exosome-Based Therapy Clinical Trial

The 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 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,...

The 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. As no approved pharmacological therapies currently exist beyond reperfusion treatments for stroke, SNE-101's potential neuroregenerative, neuroprotective, and anti-inflammatory effects offer new hope for improving recovery in stroke patients.

Media Contact:

Jae Bok Ban
COO, Business Development Division, S&E bio
[email protected] 

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