Silo Pharma Inc. (NASDAQ: SILO) has 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.
According to the company, 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, which could accelerate the development timeline.
This announcement is significant as it marks a key step forward in Silo's efforts to address PTSD, a condition affecting millions worldwide. The intranasal delivery system offers a non-invasive route of administration, which could improve patient compliance and provide rapid onset of action. The robustness study ensures the device performs consistently, a critical factor for regulatory approval and eventual commercialization.
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 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 implications of this announcement extend beyond Silo. If successful, SPC-15 could become a first-in-class prophylactic treatment for PTSD, potentially reducing the burden on healthcare systems and improving quality of life for patients. The use of the 505(b)(2) pathway could also set a precedent for other drug-device combinations targeting psychiatric disorders. For investors, progress toward an IND filing and Phase 1 trial represents a de-risking of the asset, which could impact the company's valuation.
More information about Silo Pharma is available at silopharma.com. The latest news and updates relating to SILO are available in the company's newsroom at https://nnw.fm/SILO.
