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Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories
Globenewswireยท 2025-05-14 12:40
Core Insights - Silo Pharma, Inc. has entered into an agreement with Frontage Laboratories for a 7-day safety and toxicology study of its lead asset SPC-15, an intranasal treatment for PTSD, as requested by the FDA [1][2] - The company is on track to submit an Investigational New Drug (IND) application to the FDA this year, with positive preclinical data expected to support this submission in 2025 [2] - Silo Pharma has an exclusive global license from Columbia University to develop, manufacture, and commercialize SPC-15 [3] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and CNS diseases [6] - The company's portfolio includes innovative programs such as SPC-15 for PTSD and SP-26 for fibromyalgia and chronic pain, along with preclinical assets targeting Alzheimer's disease and multiple sclerosis [6] Product Details - SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders like PTSD and anxiety [4] - The product may qualify for the FDA's streamlined 505(b)(2) regulatory pathway, potentially accelerating the approval process [4] Collaboration and Research - Silo Pharma collaborates with leading universities and laboratories for its research initiatives [6] - Frontage Laboratories, a global CRO, is involved in the safety and toxicology study for SPC-15, enhancing the company's research capabilities [5]