Silo Pharma Advances SPC-15 Intranasal PTSD Program With Device Robustness Study

Silo Pharma Inc. (NASDAQ: SILO) announced that its drug-device development partner Resyca will conduct a robustness study of the microchip-based Soft-Mist Nasal Spray system used to deliver SPC-15, the company’s lead intranasal prophylactic treatment candidate for post-traumatic stress disorder (PTSD). The study will evaluate device performance consistency and the stability of SPC-15 and placebo formulations over a 30-day period, supporting the combination product’s regulatory pathway.

The study is expected to support Silo’s planned FDA Type C meeting request, where the company intends to seek regulatory guidance on its investigational new drug (IND) strategy and Phase 1 clinical trial design. Silo previously aligned with the FDA on pursuing the streamlined 505(b)(2) regulatory pathway for SPC-15 following a pre-IND meeting. The robustness data will be critical for demonstrating the reliability and consistency of the intranasal delivery system, which is a key component of the drug-device combination product.

SPC-15 is designed as a prophylactic treatment for PTSD, addressing a significant unmet need in stress-induced psychiatric disorders. The broader Silo portfolio includes innovative programs such as SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease and multiple sclerosis. Silo’s research is conducted in collaboration with leading universities and laboratories, as noted in the press release.

The company’s therapeutic focus is on underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. According to the announcement, the robustness study is a pivotal step toward advancing SPC-15 into clinical development. The U.S. Food and Drug Administration’s (FDA) 505(b)(2) pathway allows for reliance on existing safety and efficacy data, potentially accelerating the approval process for SPC-15.

This development underscores the importance of drug-device combination products in delivering targeted therapies. The intranasal route offers advantages for rapid onset and ease of administration, which could be beneficial for PTSD patients. Silo’s collaboration with Resyca highlights the specialized expertise required to develop and validate such delivery systems.

For more information, the full press release is available at https://nnw.fm/Yzvx7. Updates on Silo Pharma can be found in the company’s newsroom at https://nnw.fm/SILO.

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