Silo Pharma reports positive preclinical study results for SP-26, a ketamine implant, showing safety and sustained drug release.
Quiver AI Summary
Silo Pharma, Inc. announced positive preclinical results for its novel extended-release ketamine implant, SP-26, targeting fibromyalgia treatment. The study demonstrated strong tolerability, safety, and sustained drug release, meeting all endpoints such as survival and neurological assessments in minipigs. SP-26 is designed to deliver ketamine at controlled rates, avoiding the dissociative effects of traditional IV injections while providing a non-addictive alternative to opioids. The findings position Silo for potential clinical studies, with hopes that SP-26 could become the first injectable ketamine therapeutic for at-home use, aligning with FDA requirements for new pain management approaches.
Potential Positives
- Positive preclinical study results for SP-26, indicating strong tolerability and safety as a long-acting treatment for fibromyalgia.
- All study endpoints met, including survival and clinical observations, indicating a successful evaluation of SP-26 in minipigs.
- SP-26's sustained ketamine release and minimal tissue reaction position the company favorably for potential FDA approval and therapeutic designation.
- The potential for SP-26 to become the first at-home injectable ketamine-based therapeutic could significantly expand Silo Pharma's market opportunities.
Potential Negatives
- The press release heavily relies on forward-looking statements, indicating uncertainty about future outcomes and potential regulatory hurdles that could impact the success of SP-26.
- The emphasis on the preclinical stage and lack of any mention of clinical trial results may raise concerns about the actual efficacy and applicability of SP-26 in treating fibromyalgia and chronic pain in humans.
- There is a potential lack of differentiation from existing treatments, as the release does not clearly state how SP-26 compares with currently available therapies beyond its delivery method.
FAQ
What are the key findings of the SP-26 preclinical study?
The SP-26 study demonstrated strong tolerability, sustained drug release, and a favorable safety profile in minipigs.
How does SP-26 differentiate from traditional ketamine treatments?
SP-26 offers controlled, sustained-release of ketamine, reducing the risk of dissociation and avoiding addictive opioids.
What is the potential regulatory pathway for SP-26?
If successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
What conditions is Silo Pharma targeting with SP-26?
SP-26 is focused on treating chronic pain and fibromyalgia, as well as stress-induced psychiatric disorders.
What is the significance of the study's results for Silo Pharma?
The positive results position Silo Pharma to advance SP-26 into clinical studies and expand its therapeutic pipeline.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SILO Insider Trading Activity
$SILO insiders have traded $SILO stock on the open market 3 times in the past 6 months. Of those trades, 3 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $SILO stock by insiders over the last 6 months:
- ERIC WEISBLUM (CEO and President) has made 3 purchases buying 7,500 shares for an estimated $6,721 and 0 sales.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$SILO Hedge Fund Activity
We have seen 8 institutional investors add shares of $SILO stock to their portfolio, and 5 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- RENAISSANCE TECHNOLOGIES LLC removed 189,506 shares (-83.5%) from their portfolio in Q4 2024, for an estimated $168,660
- UBS GROUP AG added 20,085 shares (+inf%) to their portfolio in Q4 2024, for an estimated $17,875
- CONNING INC. added 20,000 shares (+inf%) to their portfolio in Q1 2025, for an estimated $23,400
- VIRTU FINANCIAL LLC removed 15,185 shares (-59.3%) from their portfolio in Q4 2024, for an estimated $13,514
- XTX TOPCO LTD added 14,563 shares (+inf%) to their portfolio in Q4 2024, for an estimated $12,961
- CITADEL ADVISORS LLC removed 14,373 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $12,791
- HRT FINANCIAL LP added 11,448 shares (+inf%) to their portfolio in Q4 2024, for an estimated $10,188
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
— Successfully demonstrates strong tolerability, sustained drug release and safety
SARASOTA, FL, April 30, 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 positive results for its preclinical study evaluating SP-26, a novel extended-release ketamine implant which it believes supports SP-26’s potential as a safe, well-tolerated, and long-acting treatment for fibromyalgia.
All study endpoints were met, including survival, clinical observations, body weight stability, neurological assessments, and histopathological evaluation.
“Our team is pleased to report that SP-26 met all expectations in this preclinical study,” said Eric Weisblum, CEO of Silo Pharma. “We believe these results support the advancement of SP-26 as a next-generation therapeutic for fibromyalgia, combining the proven efficacy of ketamine with the safety and convenience of extended-release delivery.”
The study, which was conducted in minipigs, evaluated the pharmacokinetics, safety, and local tolerability of SP-26 formulations when administered subcutaneously. SP-26 implants are designed to deliver ketamine at a controlled rate, avoiding the dissociative effects associated with IV bolus injection and providing a viable alternative to highly addictive opioid treatments. The preclinical results position Silo to advance toward clinical studies and expand the Company’s pipeline for chronic pain and mental health indications.
Study Highlights:
• Safety Profile: No implant-related adverse events were observed. Animals maintained a healthy weight, normal neurological behavior, and full survival to study conclusion.
• Sustained Drug Release: Ketamine was steadily released post-implantation, with measurable systemic exposure achieved across all dose levels. Peak drug levels were reached within 1 hour in most subjects, with sustained plasma concentrations observed for up to 22 days.
• Minimal Tissue Reaction: Both formulations elicited only minimal to mild chronic inflammation at the implant sites, with no dose-dependent or formulation-specific differences.
“SP-26 has been designed to offer a new approach to pain management by providing sustained, sub-psychedelic levels of ketamine in an abuse-deterrent format,” Weisblum added. “Preclinical SP-26 research overall has focused on ensuring that the safety profile of SP-26 aligns with FDA requirements for potential at-home therapeutic designation. If approved, SP-26 could become the first at-home injectable ketamine-based therapeutic.”
About SP-26
SP-26 is a ketamine-based injectable dissolvable polymer implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment. If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
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.
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