Silo Pharma Partners with Resyca for SPC-15 Device Robustness Study

Silo Pharma announced that it has engaged its drug-device development partner Resyca to conduct a robustness study evaluating the microchip-based nasal spray system used for nose-to-brain delivery of SPC-15, the company's lead intranasal prophylactic treatment for post-traumatic stress disorder. Silo believes this approach has the potential to increase drug concentrations in the brain while reducing systemic exposure, potentially enabling faster therapeutic onset and an improved safety profile. Drug-device robustness testing is a standard component of combination-product development and is intended to demonstrate consistent device performance and formulation stability prior to clinical evaluation. Silo's robustness study will evaluate device performance consistency during expected use and assess formulation stability of SPC-15 formulations over a 30-day period. The FDA IND Type C meeting is a formal interaction with the FDA to obtain regulatory feedback on drug development programs outside of standard milestone meetings. In a previous pre-IND meeting with the FDA, Silo successfully aligned with the FDA on the streamlined 505 regulatory pathway for approval of SPC-15.