Silo Pharma Advances SPC-15 PTSD Therapeutic with Drug-Device Robustness Study Ahead of Planned FDA Type C Meeting Request
Study designed to evaluate performance and formulation stability of proprietary nose-to-brain delivery system
SARASOTA, FLA., June 29, 2026 (GLOBE NEWSWIRE) — Silo Pharma (Nasdaq: SILO) (“Silo” or “the Company”), a diversified developmental-stage biopharmaceutical company with a therapeutic focus on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases, today 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 (PTSD).
“We believe this robustness study represents another important step toward initiating our first-in-human clinical program for SPC-15,” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “Together with our previously completed preclinical studies, these data are expected to support our planned FDA Type C meeting request, where we intend to obtain regulatory guidance on our IND strategy and Phase 1 clinical trial design.”
Resyca’s patented Soft-Mist Nasal Spray system is designed for targeted nose-to-brain drug delivery, enabling molecules to bypass the blood-brain barrier. 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 (lead and placebo) over a 30-day period.
The U.S. Food and Drug Administration’s (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(b)(2) regulatory pathway for approval of SPC-15.
About Silo Pharma, Inc.
Silo Pharma is a diversified developmental-stage biopharmaceutical company with a therapeutic focus on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company’s portfolio includes innovative programs such as SPC-15 for post-traumatic stress disorder (PTSD), SP-26 for fibromyalgia and chronic pain, and a preclinical asset targeting Alzheimer’s disease. Silo’s research is conducted in collaboration with leading universities and laboratories. silopharma.com
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