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Silo Pharma Achieves Key Milestone with First Dosing in IND-Enabling GLP Study for SPC-15 as a Groundbreaking PTSD Treatment
Preclinical Data to Support Advancement Toward First-in-Human Clinical Trials SARASOTA, FL, March 26, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq:
About this update from Silo Pharma, Inc.
[{"type":"text","content":"Preclinical Data to Support Advancement Toward First-in-Human Clinical Trials SARASOTA, FL, March 26, 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 first dosing in an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). “This IND-enabling safety study and our concurrent GLP-compliant pharmacokinetic and pharmacodynamic study, if successful, will provide the last preclinical data needed to open an IND for SPC-15,” said Eric Weisblum, CEO of Silo. “We are following the FDA’s helpful responses to our pre-IND submission, which provide a clear path to an IND submission to first-in-human clinical studies.” Silo Pharma completed a pre-IND meeting in September 2024 to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 and review the Company’s proposed plan to support opening an IND. The FDA’s 505(b)(2) drug development route can significantly shorten clinical timelines for FDA approval and reduce drug development costs. About SPC-15SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders such as PTSD and anxiety. With its potential eligibility for the FDA’s streamlined 505(b)(2) regulatory pathway, SPC-15 offers a promising approach to accelerate the approval process. Silo Pharma is collaborating with Columbia University to conduct preclinical studies and has exclusive global rights to the development and commercialization of SPC-15. About Silo PharmaSilo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. 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. Silo’s research is conducted in collaboration with leading universities and laboratories. silopharma.com Forward-Looking StatementsThis news release contains \"fo...