Silo Pharma Announces Completion of Dosing in Safety Study of PTSD Drug SPC-15
Rhea-AI Summary
Silo Pharma (Nasdaq: SILO) has completed dosing in a FDA-requested 7-day safety and toxicology large animal study for its lead PTSD drug candidate SPC-15. The bioanalytical and safety/toxicology results are expected within 60 days.
The company is progressing with two remaining preclinical studies: an IND-enabling GLP-compliant toxicology study and a device study for SPC-15's microchip-based nasal spray system. Silo plans to pursue the FDA's 505(b)(2) regulatory pathway for SPC-15's approval, which could potentially accelerate clinical timelines and reduce development costs.
Positive
- Completion of FDA-requested safety and toxicology study for SPC-15
- Previous strong safety and therapeutic delivery results for SPC-15
- Pursuing 505(b)(2) pathway could reduce development time and costs
Negative
- Two additional preclinical studies still required before IND submission
- Final safety/toxicology results pending for 60 days
News Market Reaction
On the day this news was published, SILO gained 4.42%, reflecting a moderate positive market reaction. Argus tracked a peak move of +19.0% during that session. Argus tracked a trough of -8.9% from its starting point during tracking. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $220K to the company's valuation, bringing the market cap to $5M at that time. Trading volume was exceptionally heavy at 7.4x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
SARASOTA, FL, July 16, 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 completion of dosing in a U.S. Food and Drug Administration (FDA)-requested 7-day safety and toxicology large animal study of its lead asset SPC-15, and bioanalytical and safety/toxicology results for such study are expected within 60 days.
“Our novel PTSD drug candidate SPC-15 has already shown strong safety and therapeutic delivery, and we are confident about the final data results from our preclinical discovery program,” said Eric Weisblum, CEO of Silo. “We remain on track to conclude our two remaining final preclinical studies and planning to submit an investigational new drug (IND) application for SPC-15.”
Two remaining SPC-15 studies are currently in progress or being planned: an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic animal study, and a device study of SPC-15’s formulation-specific microchip-based nasal spray system.
Silo plans 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.
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 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
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.
Contact
800-705-0120
investors@silopharma.com
FAQ
What milestone did Silo Pharma (SILO) achieve for its PTSD drug SPC-15?
What regulatory pathway is Silo Pharma pursuing for SPC-15?
What studies remain before Silo Pharma can submit the IND for SPC-15?
How is SPC-15 administered to patients?
When will Silo Pharma receive the safety results for the SPC-15 study?
