Silo Pharma Advances PTSD Drug SPC-15 Toward Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025
Planned submission of IND application in 2025; Phase 1 clinical trial to follow if IND application approved
No new PTSD drug approvals in the U.S. in nearly 25 years; large potential addressable market for SPC-15 worldwide
SARASOTA, FL, July 07, 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 expects to receive data from the additional preclinical studies of its lead asset SPC-15 within the next 30 to 90 days. SPC-15 is a novel intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD).
The final drug studies are 1) an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic animal study, and 2) a U.S. Food and Drug Administration (FDA)-requested 7-day safety and toxicology large animal study. Concurrently, a device study of the formulation-specific microchip-based nasal spray system used in SPC-15 is being conducted.
Early data on SPC-15 indicated that its optimized patient safety profile and therapeutic delivery may provide additive benefits for combating stress-induced pathophysiology at both the behavioral and neural levels.
Eric Weisblum, CEO of Silo, stated, “As we await pre-clinical data within the next 90 days, we currently anticipate initiating the IND application for SPC-15 before the end of the year, assuming positive data results. If submitted and approved, this will be a pivotal achievement along our path to first-in-human trials. If the FDA approves our IND within the 30-day review period, we could initiate a Phase 1 clinical trial before the end of 2026.
“Moving forward, we intend to seek the FDA’s 505(b)(2) regulatory pathway for approval of SPC-15, a drug development route that can significantly shorten clinical timelines for FDA approval and reduce drug development costs,” Weisblum added.
Only two drugs are currently approved by the FDA for treating PTSD, both of which primarily target the depressive effects of the condition. In contrast, SPC-15’s differentiated method of action is designed to increase stress resilience in high-risk populations. There have been no new drug approvals in nearly 25 years for the condition that affects an estimated 3.9% of the world’s population.1
About SPC-15
SPC-15 is an intranasal 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 Pharma
Silo 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
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1 FT Specialist, Endpoints in Focus, Lykos’ pain is others’ gain…., June 2024.
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