Silo Pharma initiates safety study for PTSD drug SPC-15

Silo Pharma, Inc., a biopharmaceutical company focused on developing novel treatments, has commenced a critical safety study for its lead drug, SPC-15, which targets post-traumatic stress disorder (PTSD). On May 14, 2025, the company announced its collaboration with Frontage Laboratories to conduct a 7-day safety and toxicology study involving large animals. This research is part of the Food and Drug Administration (FDA) requirements aimed at supporting Silo’s Investigational New Drug (IND) application for SPC-15.

Eric Weisblum, CEO of Silo Pharma, stated, “We are conducting a 7-day safety and toxicology study to gather additional data that is expected to supplement and reinforce our SPC-15 IND application to the FDA.” The company aims to submit its application by the end of this year, contingent upon the positive outcomes of this study.

In addition to the safety study, Silo Pharma is also conducting a separate Good Laboratory Practice (GLP) compliant study focusing on toxicology and toxicokinetics of SPC-15. The results from these preclinical studies are critical, as they will inform the IND submission scheduled for 2025. If approved by the FDA, Silo will advance to a first-in-human Phase 1 clinical trial for SPC-15.

SPC-15 is designed as an intranasal treatment that acts as a serotonin 5-HT4 receptor agonist to address stress-induced psychiatric disorders, including PTSD and anxiety. Its eligibility for the FDA’s expedited 505(b)(2) regulatory pathway could accelerate its approval, adding to the urgency of the ongoing studies.

Silo Pharma has partnered with Columbia University, which has provided an exclusive global license to develop, manufacture, and commercialize SPC-15. This collaboration enhances Silo’s research capabilities, positioning it to make significant strides in treating PTSD.

Silo Pharma’s portfolio also includes other innovative programs targeting conditions like fibromyalgia, chronic pain, Alzheimer’s disease, and multiple sclerosis. The company emphasizes its commitment to addressing underserved medical needs through research in collaboration with leading academic institutions.

As the mental health landscape continues to evolve, Silo Pharma’s advancements in PTSD treatment could offer new hope for individuals affected by this debilitating condition. The ongoing studies and potential clinical trials represent a significant step forward in the search for effective therapies for PTSD.