Full Press Release Details
— 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.
• 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.”
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.
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
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