Silo Pharma Announces Positive Initial Pharmacokinetic, Safety, and Tolerability Study of SP-26 for Chronic Pain and Fibromyalgia

Rhea-AI Summary

Silo Pharma (NASDAQ: SILO) reported positive initial results from its ongoing study of SP-26, a novel ketamine extended-release rod implant designed for chronic pain and fibromyalgia treatment. The non-GLP small animal testing, which began in December 2024, showed no serious side effects or discomfort following implantation in early January 2025.

The SP-26 implant is being developed as a self-administered, non-opioid therapeutic. The study is currently in the final stages of Absorption, Distribution, Metabolism, and Excretion (ADME) testing, with final safety and pharmacokinetic reports expected in March 2025.

Positive

• Initial safety data shows no serious side effects or discomfort in animal testing
• Study progressing on schedule with final results expected March 2025

Negative

• Still in early preclinical stage with no human trial data
• Final safety and absorption data yet to be confirmed

Insights

Pharmaceutical Research Analyst

The preliminary results from Silo Pharma's SP-26 preclinical study represent a significant milestone in addressing the $130 billion global chronic pain market. The development of a subcutaneous ketamine implant is particularly noteworthy as it could revolutionize pain management through controlled release technology, potentially offering sustained relief without the addiction risks associated with opioids.

The absence of serious adverse effects in the animal study is particularly encouraging, as safety is a primary concern in novel drug delivery systems. The subcutaneous rod format could solve several key challenges in ketamine therapeutics: controlled dosing, improved bioavailability and patient compliance. The non-GLP study, while preliminary, is a important step that typically precedes the more rigorous GLP toxicology studies required for IND (Investigational New Drug) submission.

Looking ahead, the March 2025 ADME data will be critical in determining the drug's:

• Absorption rate and bioavailability through the subcutaneous route
• Distribution patterns throughout the body
• Metabolic pathway and potential drug interactions
• Elimination profile and duration of therapeutic effect

If the final data package confirms these initial positive signals, Silo Pharma could potentially advance to GLP toxicology studies by late 2025, setting the stage for potential IND filing in 2026. However, investors should note that early-stage drug development carries significant risks and successful animal studies don't guarantee clinical efficacy in humans.

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. 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.

Contact

800-705-0120
investors@silopharma.com

FAQ

What are the initial results of Silo Pharma's SP-26 ketamine implant study?

The initial results from the preclinical animal study showed no serious side effects or discomfort following implantation in January 2025, with final safety and pharmacokinetic reports expected in March 2025.

When will SILO release the final SP-26 study results?

Silo Pharma expects to release the final safety and pharmacokinetic reports for the SP-26 study in March 2025.

What conditions is SILO's SP-26 ketamine implant designed to treat?

SP-26 is being developed as a self-administered, non-opioid therapeutic intended for the treatment of chronic pain and fibromyalgia.

When did SILO begin the preclinical testing of SP-26?

Silo Pharma launched the non-GLP small animal testing of SP-26 in December 2024, with implantation completed in the first week of January 2025.