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. 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 application.
The company expects the study 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. The 505(b)(2) pathway allows for reliance on existing safety and efficacy data, potentially accelerating development.
Silo Pharma is a diversified developmental-stage biopharmaceutical company whose 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.
The robustness study is a critical step in demonstrating the reliability of the drug-device combination, which could differentiate SPC-15 from existing PTSD treatments. Intranasal delivery offers rapid onset and bypasses first-pass metabolism, potentially improving bioavailability and patient compliance. If successful, SPC-15 could become a first-in-class prophylactic for stress-induced psychiatric disorders.
For more details, visit the full press release at https://nnw.fm/Yzvx7. The latest news and updates relating to SILO are available in the company’s newsroom at https://nnw.fm/SILO.
