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 path to regulatory approval.
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 pathway could accelerate development by leveraging existing safety data.
SPC-15 is a proprietary intranasal formulation designed for prophylactic treatment of stress-induced psychiatric disorders. The robustness study is a critical step in validating the drug-device combination, ensuring consistent dosing and formulation stability. According to Silo, the results will help de-risk the development program and strengthen the regulatory submission package.
Beyond SPC-15, Silo Pharma's pipeline includes SP-26 for fibromyalgia and chronic pain, as well as preclinical assets targeting Alzheimer's disease and multiple sclerosis. The company's research is conducted in collaboration with leading universities and laboratories. Silo also operates as a cryptocurrency treasury company, holding digital assets as part of its corporate strategy.
The PTSD treatment landscape has seen increasing interest in novel delivery methods. Intranasal administration offers rapid onset and bypasses first-pass metabolism, potentially improving patient outcomes. If successful, SPC-15 could become a first-in-class prophylactic for PTSD, addressing a significant unmet need in stress-induced psychiatric disorders.
For more information on Silo Pharma, visit the company's newsroom at https://nnw.fm/SILO. The full press release is available at https://nnw.fm/Yzvx7.
