Silo Pharma's PTSD Candidate SPC-15 Achieves Positive Safety Milestone, Paving Way for Accelerated Clinical Trials Under 505(b)(2) Pathway

Core Insights - Silo Pharma, Inc. announced positive bioanalytical and safety/toxicology results for its SPC-15 intranasal spray formulation, meeting FDA safety standards for clinical trials [1][2] - The study demonstrated that SPC-15's intranasal administration has comparable systemic exposure to oral administration while showing no identified toxicities, supporting its potential as a PTSD therapeutic [2][3] - The company is pursuing a 505(b)(2) regulatory strategy to streamline the FDA approval process by leveraging existing safety and efficacy data from approved drugs [3] Company Developments - Silo is conducting an IND-enabling GLP-compliant toxicology study and evaluating clinical CRO sites for first-in-human trials of SPC-15 [4] - The company focuses on addressing underserved conditions, including PTSD, chronic pain, and CNS diseases, with a portfolio that includes SPC-15 and other innovative programs [5] Market Insights - The PTSD market size was valued at $1.8 billion in 2024 and is projected to reach $3.2 billion by 2034, driven by increased focus on mental health and personalized treatment solutions [5]