Silo Pharma's SP-26 Ketamine Implant Meets All Endpoints in Fibromyalgia Study

— 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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