SARASOTA, Fla., June 29, 2026
Silo Pharma announced that it has initiated a drug-device robustness study for SPC-15, its lead investigational intranasal prophylactic therapy for post-traumatic stress disorder (PTSD), as the company prepares for a planned FDA Type C meeting. The study will be conducted in collaboration with Resyca, Silo’s drug-device development partner, and is designed to evaluate the performance and formulation stability of the company’s proprietary microchip-based Soft-Mist Nasal Spray system. The data generated are expected to support Silo’s regulatory strategy and planned Investigational New Drug (IND) submission as the company advances SPC-15 toward its first-in-human Phase 1 clinical trial. The announcement represents another important milestone in the development of a novel nose-to-brain drug delivery platform aimed at treating stress-induced psychiatric disorders.
Study Evaluates Device Performance and Formulation Stability
The robustness study will assess the consistency of the nasal spray device during expected clinical use while simultaneously evaluating the stability of SPC-15 formulations, including both the lead formulation and placebo, over a 30-day testing period. According to Silo Pharma, robustness testing is a critical requirement for drug-device combination products, helping demonstrate reliable device performance and consistent formulation quality before clinical evaluation begins. The company believes that Resyca’s patented Soft-Mist Nasal Spray technology offers significant advantages by enabling targeted nose-to-brain delivery, allowing therapeutic molecules to bypass the blood-brain barrier. This approach has the potential to increase drug concentrations within the brain while reducing systemic exposure, potentially resulting in faster therapeutic onset, improved efficacy, and an enhanced safety profile compared with conventional drug delivery methods.
FDA Type C Meeting Expected to Guide IND and Phase 1 Development
The data generated from the robustness study, together with previously completed preclinical studies, will support Silo Pharma’s planned request for an FDA Type C meeting, where the company intends to seek regulatory feedback regarding its IND strategy and the design of its planned Phase 1 clinical trial. Type C meetings provide sponsors with an opportunity to discuss important regulatory questions outside standard development milestones and are often used to clarify clinical, manufacturing, and regulatory requirements before advancing investigational therapies. Silo previously completed a successful pre-IND meeting with the FDA, during which the agency agreed with the company’s proposed 505(b)(2) regulatory pathway, potentially providing a more streamlined development and approval process for SPC-15 by leveraging existing scientific and regulatory data where appropriate.
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Silo Continues Expanding CNS and Psychiatric Disease Pipeline
SPC-15 remains the lead asset within Silo Pharma’s growing pipeline of therapies targeting central nervous system (CNS) disorders and underserved psychiatric conditions. The company is focused on developing innovative treatments for diseases with significant unmet medical needs, including post-traumatic stress disorder, chronic pain, fibromyalgia, and Alzheimer’s disease. Alongside SPC-15, Silo is advancing SP-26 for fibromyalgia and chronic pain while continuing preclinical development of additional CNS programs through collaborations with leading universities and research laboratories. With the robustness study now underway and regulatory interactions progressing, Silo aims to initiate first-in-human clinical development of SPC-15 and further validate its proprietary nose-to-brain drug delivery platform as a differentiated approach for treating neurological and psychiatric disorders.
Source: Silo Pharma, press release
