regulatory
confidence high
sentiment neutral
materiality 0.60
Silo Pharma submits pre-IND to FDA for SPC-15 intranasal PTSD treatment
Silo Pharma, Inc.
- SPC-15 is an intranasal prophylactic treatment for PTSD and stress-induced anxiety disorder.
- Pre-clinical data showed effective, consistent exposure in a non-GLP small animal study completed Feb 2024.
- Silo expects to finalize an exclusive worldwide license with Columbia University in H1 2024.
- Next steps: PIND and GLP studies both slated to commence in H2 2024 before IND submission.
- Only two FDA-approved PTSD drugs exist; SPC-15 aims to increase stress resilience in high-risk populations.