Project UpdateJun 29, 2026, 04:16 PM
Silo Pharma Initiates Robustness Study for SPC-15 Delivery System
AI Summary
Silo Pharma announced it has engaged Resyca to conduct a robustness study evaluating the microchip-based nasal spray system for SPC-15, its lead intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). This study is designed to assess device performance consistency and formulation stability over 30 days. The data from this study is expected to support a planned FDA Type C meeting request to obtain regulatory guidance for its IND strategy and Phase 1 clinical trial design, following a previous alignment with the FDA on a streamlined 505(b)(2) regulatory pathway for SPC-15.
Key Highlights
- Silo Pharma engaged Resyca for a robustness study of its SPC-15 nasal spray system.
- The study evaluates device performance and formulation stability over a 30-day period.
- This study is a step towards initiating first-in-human clinical program for SPC-15.
- Data from the study will support a planned FDA Type C meeting request.
- Silo Pharma previously aligned with FDA on a streamlined 505(b)(2) pathway for SPC-15.
- SPC-15 is Silo's lead intranasal prophylactic treatment for PTSD.
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