Silo Pharma Achieves Key Milestone with First Dosing in IND-Enabling GLP Study for SPC-15 as a Groundbreaking PTSD Treatment
Rhea-AI Summary
Silo Pharma (Nasdaq: SILO) has announced a significant milestone in the development of its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). The company has initiated first dosing in an IND-enabling GLP-compliant toxicology and toxicokinetics study.
Following a successful pre-IND meeting with the FDA in September 2024, Silo is pursuing the 505(b)(2) regulatory pathway for SPC-15's approval. This pathway is designed to potentially reduce clinical development timelines and costs. The current studies, if successful, will provide the final preclinical data required for submitting an IND application and advancing to first-in-human clinical trials.
Positive
- Achieved first dosing milestone in IND-enabling GLP study
- FDA provided clear regulatory pathway through 505(b)(2) route
- Potential for shortened development timeline and reduced costs through 505(b)(2) pathway
Negative
- Still in preclinical phase with no human trial data yet
- Success of current studies required before IND submission
News Market Reaction
On the day this news was published, SILO gained 1.49%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Preclinical Data to Support Advancement Toward First-in-Human Clinical Trials
SARASOTA, FL, March 26, 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 first dosing in an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
“This IND-enabling safety study and our concurrent GLP-compliant pharmacokinetic and pharmacodynamic study, if successful, will provide the last preclinical data needed to open an IND for SPC-15,” said Eric Weisblum, CEO of Silo. “We are following the FDA’s helpful responses to our pre-IND submission, which provide a clear path to an IND submission to first-in-human clinical studies.”
Silo Pharma completed a pre-IND meeting in September 2024 to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 and review the Company’s proposed plan to support opening an IND. The FDA’s 505(b)(2) drug development route 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 treatment in March 2025?
When did Silo Pharma complete its pre-IND meeting with the FDA for SPC-15?
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What is the next major milestone for Silo Pharma's SPC-15 PTSD treatment?
