Silo Pharma completes dosing in safety study of SPC-15

Silo Pharma (SILO) announced completion of dosing in a U.S. Food and Drug Administration-requested 7-day safety and toxicology large animal study of its lead asset SPC-15, and bioanalytical and safety/toxicology results for such study are expected within 60 days. Two remaining SPC-15 studies are currently in progress or being planned: an IND-enabling GLP-compliant toxicology and toxicokinetic animal study, and a device study of SPC-15’s formulation-specific microchip-based nasal spray system. Silo plans to seek the FDA’s 505(b)(2) regulatory pathway for approval of SPC-15, a drug development route that can significantly shorten clinical timelines for FDA approval and reduce drug development costs.