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 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. This approach could potentially expedite development by leveraging existing safety and efficacy data from approved drugs.
SPC-15 is designed as a prophylactic treatment for PTSD, targeting individuals at high risk of exposure to traumatic events, such as military personnel or first responders. The intranasal delivery system aims to provide rapid onset and ease of administration. Silo's portfolio includes other programs such as SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer's disease and multiple sclerosis. The company's research is conducted in collaboration with leading universities and laboratories.
The robustness study is a critical step in validating the drug-device combination for clinical use. Consistent device performance ensures reliable dosing, which is essential for both safety and efficacy in future trials. The 30-day stability assessment will also provide data on the formulation's shelf life and handling conditions.
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 diseases. The company's pipeline reflects a commitment to innovative solutions for conditions with limited treatment options.
For more information, visit the company's newsroom at https://nnw.fm/SILO and the full press release at https://nnw.fm/Yzvx7.
