Silo Pharma (SILO) announced that it has selected Allucent, a global full-service clinical research organization, CRO, to support the Company’s final preparations and planned submission of its investigational new drug application, IND, to the FDA for a Phase 1 clinical trial of its intranasal prophylactic SPC-15 as a treatment for PTSD. The Company currently expects to submit the IND in 2026 and commence its first-in-human, FIH, SPC-15 trial subsequent to FDA approval. Data from an IND-enabling GLP-compliant toxicology and toxicokinetic study, along with findings from a drug-device study of the formulation-specific intranasal spray system used for SPC-15 drug delivery, are expected in early 2026. Silo intends to pursue the FDA’s 505(b)(2) accelerated regulatory pathway for clinical development of SPC-15.
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