Silo Pharma Initiates Safety Study for PTSD Drug SPC-15

LOS ANGELES- Silo Pharma Inc. a developmental-stage biopharmaceutical company, has commenced a 7-day safety and toxicology study for its lead candidate, SPC-15, an intranasal treatment targeting post-traumatic stress disorder (PTSD). The study is being conducted at Frontage Laboratories, a contract research organization, to gather additional data in support of an upcoming Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) .

SPC-15 is designed as a serotonin 5-HT4 receptor agonist, administered intranasally, intended for the treatment of stress-induced psychiatric disorders such as PTSD and anxiety. The drug’s development is being carried out in collaboration with Columbia University, which has granted Silo Pharma an exclusive global license for its development, manufacturing, and commercialization .

In addition to the current safety study, Silo Pharma is conducting a separate Good Laboratory Practice (GLP)-compliant toxicology and toxicokinetic study of SPC-15. The outcomes of these studies are expected to support the IND submission process. Upon FDA approval of the IND, Silo Pharma plans to initiate a first-in-human Phase 1 clinical trial for SPC-15 .

The company anticipates submitting the IND application in 2025. SPC-15 may be eligible for the FDA’s 505(b)(2) regulatory pathway, which could potentially expedite the drug approval process .

Silo Pharma’s pipeline includes other investigational therapies targeting conditions such as fibromyalgia, chronic pain, Alzheimer’s disease, and multiple sclerosis. The company’s research efforts are conducted in collaboration with various academic institutions and laboratories .