Full Press Release Details
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
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.
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
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law.
1 FT Specialist, Endpoints in Focus, Lykos’ pain is others’ gain…., June 2024.