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.
SPC-15 is designed as a prophylactic treatment for stress-induced psychiatric disorders, including PTSD. The intranasal delivery system aims to provide rapid onset and improved bioavailability compared to oral formulations. This approach could address a significant unmet need in the PTSD treatment landscape, where current therapies often have delayed onset or limited efficacy.
The robustness study is a critical step in advancing SPC-15 toward clinical trials. By evaluating device performance and formulation stability over 30 days, the study will help ensure consistent dosing and product quality, which are essential for regulatory approval. The results will inform the design of Phase 1 trials and support the company's dialogue with the FDA.
For business leaders and investors, this development signals Silo Pharma's progress in advancing its pipeline of CNS-focused therapies. Beyond SPC-15, the company's portfolio includes SP-26 for fibromyalgia and chronic pain, as well as preclinical assets targeting Alzheimer's disease and multiple sclerosis. Silo's research is conducted in collaboration with leading universities and laboratories.
The potential impact of a successful intranasal PTSD prophylactic could be substantial. PTSD affects millions globally, with current treatments often limited by side effects or slow onset. A rapid-acting, easy-to-administer therapy could improve patient outcomes and reduce the burden on healthcare systems. For the industry, this represents an innovative approach to psychiatric drug delivery that may have applications beyond PTSD.
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 CNS diseases. For more information, visit the company's newsroom at https://nnw.fm/SILO.
The full press release is available at https://nnw.fm/Yzvx7.
