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 advancement.
The company stated that the study is expected to support its planned FDA Type C meeting request, where it 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.
Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company. Its therapeutic focus is 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 PTSD, 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.
This development is significant as it moves SPC-15 closer to clinical trials. PTSD affects millions worldwide, and current treatments are often inadequate. An intranasal prophylactic could offer a novel approach to prevent or mitigate symptoms. The robustness study is a critical step in ensuring the delivery system is reliable and the drug remains stable, which are essential for regulatory approval and eventual patient use.
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