Silo Pharma Announces Positive Initial Pharmacokinetic, Safety, and Tolerability Study of SP-26 for Chronic Pain and Fibromyalgia
No serious side effects or discomfort observed
Final safety and absorption data expected in March 2025
SARASOTA, FL, Feb. 11, 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 a positive update from an ongoing study evaluating the pharmacokinetics, safety and tolerability of its novel SP-26 ketamine extended-release rods when implanted subcutaneously. The SP-26 implant is a novel self-administered, non-opioid therapeutic intended for the treatment of chronic pain and fibromyalgia.
The launch of our non-GLP study in December 2024 marked the first small animal testing of SP-26, a key preclinical milestone. Implantation (dosing) was completed in the first week of January 2025 and no animals experienced serious side effects or discomfort. Absorption, distribution, metabolism, and excretion (ADME) testing is nearing completion and final safety, and pharmacokinetic reports are expected in March 2025.
“We are encouraged by the early initial data from the SP-26 animal study, with no abnormal clinical observations reported so far,” said Eric Weisblum, CEO of Silo. “We believe that a successful final outcome would provide clear, actionable data for validating the advancing of SP-26 as a potential treatment for chronic pain.”
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.
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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