Silo Pharma expects preclinical study data on SPC-15 in Q3

Silo Pharma (SILO) expects to receive data from the additional preclinical studies of its lead asset SPC-15 within the next 30 to 90 days. SPC-15 is a novel intranasal prophylactic targeting Post-Traumatic Stress Disorder. The final drug studies are an investigational new drug-enabling GLP-compliant toxicology and toxicokinetic animal study, and a U.S. Food and Drug Administration-requested 7-day safety and toxicology large animal study. Concurrently, a device study of the formulation-specific microchip-based nasal spray system used in SPC-15 is being conducted. Early data on SPC-15 indicated that its optimized patient safety profile and therapeutic delivery may provide additive benefits for combating stress-induced pathophysiology at both the behavioral and neural levels. Eric Weisblum, CEO of Silo, stated, “As we await pre-clinical data within the next 90 days, we currently anticipate initiating the IND application for SPC-15 before the end of the year, assuming positive data results. If submitted and approved, this will be a pivotal achievement along our path to first-in-human trials. If the FDA approves our IND within the 30-day review period, we could initiate a Phase 1 clinical trial before the end of 2026. Moving forward, we intend 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.”