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Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories
Clear Regulatory Path to Clinical Trials for Intranasal PTSD Therapy Targeting Multi-Billion-Dollar Market SARASOTA, FL, May 14, 2025 (GLOBE NEWSWIRE) -- Silo
About this update from Silo Pharma, Inc.
[{"type":"text","content":"Clear Regulatory Path to Clinical Trials for Intranasal PTSD Therapy Targeting Multi-Billion-Dollar Market\nSARASOTA, 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-day safety and toxicology large animal study of its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). “We are conducting a 7-day safety and toxicology study to gather additional data that is expected to supplement and reinforce our SPC-15 investigational new drug (IND) application to the FDA,” said Eric Weisblum, CEO of Silo. “We currently remain on track to begin an FDA submission this year.” The Company is currently working on a separate IND-enabling Good Laboratory Practice (GLP) -compliant toxicology and toxicokinetic study of SPC-15. Positive preclinical data from these studies, if achieved, would support an IND submission for SPC-15 in 2025. Should Silo receive approval of the IND, Silo would proceed to a first-in-human Phase 1 clinical trial for SPC-15. Columbia University, the Company’s collaboration partner for pre-clinical development, granted Silo an exclusive global license to further develop, manufacture, and commercialize SPC-15 worldwide. About SPC-15 SPC-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 FrontageFrontage Laboratories is a US-based Contract Research Organization (CRO) that was initially established in New Jersey in April 2001 and later relocated to Pennsylvania in 2004. As an FDA-registered and inspected global pharmaceutical development and manufacturing organization, we are headquartered in Exton, PA, with an impressive network of 25 ...