Core Insights - Silo Pharma, Inc. is developing SPC-15, an intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD), with plans to submit an Investigational New Drug (IND) application by the end of 2025 [1][4] - The company anticipates receiving preclinical study data for SPC-15 within 30 to 90 days, which will inform the IND application process [1][4] - SPC-15 aims to address a significant unmet need in the PTSD treatment market, as there have been no new drug approvals for PTSD in nearly 25 years, despite the condition affecting approximately 3.9% of the global population [6] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on novel therapeutics for underserved conditions, including stress-induced psychiatric disorders and chronic pain [8] - The company collaborates with Columbia University for preclinical studies and holds exclusive global rights for the development and commercialization of SPC-15 [7][8] - Silo Pharma's portfolio includes other programs targeting fibromyalgia, chronic pain, Alzheimer's disease, and multiple sclerosis [8] Drug Development Process - The final studies for SPC-15 include a Good Laboratory Practice-compliant toxicology study and a large animal safety study requested by the FDA [2] - The company plans to utilize the FDA's 505(b)(2) regulatory pathway for SPC-15, which could expedite the approval process and reduce development costs [5] - If the IND application is approved, Silo Pharma could initiate a Phase 1 clinical trial for SPC-15 by the end of 2026 [4]

Clear Regulatory Path to Clinical Trials for Intranasal PTSD Therapy Targeting Multi-Billion-Dollar MarketSARASOTA, FL, May 14, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has entered into an agreement with Frontage Laboratories, a global full-service CRO (contract research organization), for a Food and Drug Administration (FDA) requested 7 ...