Silo Pharma (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 development.
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 expedite the approval process by leveraging existing data from similar approved drugs.
SPC-15 is a prophylactic treatment aimed at preventing PTSD symptoms when administered before a traumatic event. The intranasal delivery system is designed for rapid absorption and ease of use. Silo'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 ensuring the device's reliability and the formulation's stability, which are essential for regulatory approval. By demonstrating consistent performance, Silo aims to strengthen its case for advancing SPC-15 into human trials. The company has not yet announced a timeline for the study or the Type C meeting.
According to the press release, the full details are available at https://nnw.fm/Yzvx7. For more information about Silo Pharma, visit silopharma.com. The latest news and updates relating to SILO are available in the company's newsroom at https://nnw.fm/SILO.
