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 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. The 505(b)(2) pathway allows the company to rely on existing safety and efficacy data, potentially accelerating development.
SPC-15 is designed as a prophylactic treatment for PTSD, targeting stress-induced psychiatric disorders. Silo's portfolio includes other innovative 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, as highlighted in the press release available at https://nnw.fm/Yzvx7.
The robustness study is a critical step in demonstrating the reliability of the drug-device combination, which is essential for regulatory approval. By evaluating device performance and formulation stability over 30 days, Silo aims to ensure consistent dosing and product quality. This data will be pivotal in discussions with the FDA regarding the IND strategy and Phase 1 trial design.
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 commitment to innovation is evident in its pipeline, which includes SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease and multiple sclerosis.
For the latest news and updates relating to Silo Pharma, visit the company’s newsroom at https://nnw.fm/SILO. This advancement underscores Silo's progress in developing novel therapies for underserved medical conditions, with the potential to improve outcomes for patients suffering from PTSD and other CNS disorders.
