Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories
Rhea-AI Summary
Silo Pharma (NASDAQ: SILO) has initiated a crucial 7-day safety and toxicology study for its lead drug candidate SPC-15, an intranasal PTSD treatment, at Frontage Laboratories. The study aims to gather additional data for the company's upcoming FDA investigational new drug (IND) application. Silo is simultaneously conducting a separate IND-enabling GLP-compliant toxicology study.
The company plans to submit its IND application in 2025, and upon approval, will proceed with a first-in-human Phase 1 clinical trial. SPC-15's development is backed by an exclusive global license from Columbia University for worldwide development, manufacturing, and commercialization rights.
Positive
- None.
Negative
- Still in early developmental stage with no human trial data
- Multiple regulatory hurdles remain before potential commercialization
- Timeline uncertainty for FDA approval process
News Market Reaction
On the day this news was published, SILO declined 24.00%, reflecting a significant negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Clear Regulatory Path to Clinical Trials for Intranasal PTSD Therapy Targeting Multi-Billion-Dollar Market
SARASOTA, 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 Frontage
Frontage 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 facilities spread across Pennsylvania, New Jersey, Illinois, Ohio, California, Florida, Canada, Italy, and China. We are dedicated to accelerating the development of innovative therapies by providing a broad range of science driven and quality focused services for drug discovery, DMPK, preclinical, formulation development and CTM, Analytical, clinical trials, bioanalytical and commercial-scale manufacturing.
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 the Company’s ability to successfully complete its preclinical studies and generate positive data, the risk that the FDA may not accept or may require changes to the IND, or may not allow the Company to proceed with clinical trials, the risk that the FDA may not approve
SPC-15 on the Company’s expected timeline, or at all, 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 is the current development stage of Silo Pharma's PTSD drug SPC-15?
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