Silo Pharma Inc. (Nasdaq: SILO) has announced the completion of dosing in a safety study for its PTSD drug candidate, SPC-15. This study was conducted at the request of the U.S. Food and Drug Administration (FDA) and involved a 7-day safety and toxicology assessment in a large animal model. The company anticipates receiving the bioanalytical and safety/toxicology results within 60 days. Silo Pharma is also progressing with two additional preclinical studies: an IND-enabling GLP-compliant toxicology and toxicokinetic animal study, and a device study focused on SPC-15's formulation-specific microchip-based nasal spray system. The company plans to pursue the FDA's 505(b)(2) regulatory pathway to potentially expedite the clinical approval process for SPC-15. Results from these studies are expected to be presented in the future.
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