Silo Pharma Partners with Allucent to Support Planned FDA Investigational New Drug Application for SPC-15 as a Therapeutic for PTSD
Rhea-AI Summary
Silo Pharma (Nasdaq: SILO) selected Allucent, a global clinical research organization, to support final preparations and its planned FDA IND submission in 2026 for a Phase 1 first-in-human trial of intranasal SPC-15 as a therapeutic for PTSD.
The company expects IND-enabling GLP toxicology/toxicokinetic data and a drug-device study for its formulation-specific intranasal spray system in early 2026, and intends to pursue the FDA’s 505(b)(2) accelerated pathway. Trial start is contingent on FDA IND approval; Silo described Allucent’s role as preparing dose-ranging protocols to assess SPC-15 pharmacokinetics and safety.
Positive
- IND submission expected in 2026
- GLP toxicology and toxicokinetic data expected early 2026
- Partnered with global CRO Allucent for IND preparations
- Pursuing FDA 505(b)(2) accelerated pathway
Negative
- First-in-human trial contingent on FDA IND approval
- Company expects results; preclinical positive outcomes are not guaranteed
News Market Reaction 2 Alerts
On the day this news was published, SILO declined 1.11%, reflecting a mild negative market reaction. Argus tracked a peak move of +12.3% during that session. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $62K from the company's valuation, bringing the market cap to $6M at that time.
Data tracked by StockTitan Argus on the day of publication.
SARASOTA, FL, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company), a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company, today announced that it has selected Allucent, a global full-service clinical research organization (CRO), to support the Company’s final preparations and planned submission of its investigational new drug application (IND) to the FDA for a Phase 1 clinical trial of its intranasal prophylactic SPC-15 as a treatment for PTSD. The Company currently expects to submit the IND in 2026 and commence its first-in-human (FIH) SPC-15 trial subsequent to FDA approval.
“We believe that a partnership with Allucent, is a significant move forward in bringing our novel PTSD therapeutic to the clinic,” said Silo CEO Eric Weisblum. “With Allucent’s expertise, we believe our IND will provide a sound rationale for clinical development, beginning with protocols for dose-ranging studies to assess the pharmacokinetics and safety profile for SPC-15. We expect to receive positive preclinical results in these categories which should meet the FDA’s clinical trial standards.”
Data from an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic study, along with findings from a drug-device study of the formulation-specific intranasal spray system used for SPC-15 drug delivery, are expected in early 2026. Silo intends to pursue the FDA’s 505(b)(2) accelerated regulatory pathway for clinical development of SPC-15.
About Silo Pharma
Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company. Its therapeutic focus is 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
About Allucent
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges faced by biopharma and government clients. A global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a range of therapeutic areas, Allucent brings more than 30 years of experience in over 60 countries. With an A-Team of former regulators, leading scientists, and clinical experts, Allucent’s individualized partnership approach delivers deep insights and hands-on expertise to help clients navigate the complexities of bringing innovative treatments to patients. Learn more at allucent.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
When does Silo Pharma (SILO) expect to submit the SPC-15 IND to the FDA?
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