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’s regulatory path.
The company said 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.
The robustness study is a critical step in advancing SPC-15 toward clinical trials. By ensuring the device delivers consistent doses and the drug remains stable, Silo aims to de-risk the development process and provide regulators with the data needed to approve human studies. The 30-day evaluation period covers typical use conditions, potentially accelerating the timeline to Phase 1.
For investors, this news signals progress in Silo’s pipeline and a move toward clinical-stage development. Successful completion of the study and a favorable FDA meeting could lead to a significant valuation catalyst. The 505(b)(2) pathway, which allows reliance on existing safety and efficacy data, may reduce development costs and time to market.
The broader implications for the PTSD treatment landscape are notable. SPC-15 is designed as a prophylactic, meaning it could be taken before exposure to traumatic events to prevent the onset of PTSD symptoms. If successful, it would address a significant unmet need, as current treatments focus on managing symptoms after they appear. The intranasal delivery system offers rapid absorption and ease of use, potentially improving patient compliance.
For more information, view 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.
