Silo Pharma Inc. Anticipates Key Study Results for PTSD Treatment SPC-15

Silo Pharma Inc. (NASDAQ: SILO), a developmental-stage biopharmaceutical company, is nearing a pivotal moment in the development of its lead candidate, SPC-15, a novel intranasal prophylactic aimed at enhancing stress resilience and preventing Post-Traumatic Stress Disorder (PTSD). The company has announced that it expects to receive data from two key preclinical studies within the next 30 to 90 days. These studies include IND-enabling GLP-compliant toxicology and toxicokinetic testing, alongside a large animal safety study requested by the FDA. The outcomes of these studies are critical as they will inform the planned Investigational New Drug (IND) application, which Silo Pharma aims to submit potentially before the end of the year.

The significance of SPC-15 cannot be overstated, especially in a therapeutic area that has seen no new FDA drug approvals for PTSD in nearly a quarter of a century. Silo Pharma's approach to leveraging the FDA’s 505(b)(2) pathway could expedite the development process, bringing this much-needed treatment to market more efficiently. A successful Phase 1 clinical trial, anticipated in 2026, would mark a major milestone not only for Silo Pharma but also for the millions of individuals worldwide affected by PTSD and stress-induced anxiety disorders.

This development represents a beacon of hope for the mental health community, offering the potential for a groundbreaking treatment option. The implications of SPC-15's success extend beyond the immediate benefits to patients; it could also pave the way for further innovations in the treatment of psychiatric disorders, chronic pain conditions, and central nervous system diseases. As the biopharmaceutical industry watches closely, the upcoming study results could herald a new era in the fight against PTSD.