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]

Company Overview - Silo Pharma, Inc. is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system diseases [6] - The company's portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer's disease and multiple sclerosis [6] Product Development - Silo Pharma announced positive bioanalytical and safety/toxicology results for its lead asset SPC-15, confirming that its intranasal spray formulation meets safety standards for clinical trials [1][2] - The preclinical study demonstrated that SPC-15, administered at clinical-representative doses, showed local and systemic safety with no toxicities identified, and systemic exposure was comparable to standard oral administration [2] - The company is conducting an IND-enabling GLP-compliant toxicology and toxicokinetic animal study of SPC-15, along with a device study of the formulation-specific microchip-based nasal spray system [4] Regulatory Strategy - The study data supports Silo's planned 505(b)(2) regulatory strategy for the SPC-15 program, which allows the use of previously established safety and efficacy data to streamline the FDA drug approval process and reduce development costs [3] Market Potential - The post-traumatic stress disorder market size reached $1.8 billion in 2024 and is expected to grow to $3.2 billion by 2034, driven by increasing focus on mental health support and the need for personalized treatments and integrated care solutions [5]