Silo Pharma Inc. (Nasdaq: SILO) has announced encouraging initial data from its ongoing preclinical study of SP-26, a novel ketamine extended-release implant designed for the treatment of chronic pain and fibromyalgia. The study is evaluating the pharmacokinetics, safety, and tolerability of SP-26 when administered subcutaneously.
The SP-26 implant represents a potential breakthrough in chronic pain management, offering a self-administered, non-opioid therapeutic option. This is particularly significant given the ongoing opioid crisis and the need for alternative pain relief strategies. Fibromyalgia, affecting approximately 2-4% of the U.S. population, often presents challenges in treatment, making SP-26 a potentially valuable addition to the therapeutic landscape.
Preclinical Findings
The initial data from the small animal study, which began in December 2024, indicate that the SP-26 implant was well-tolerated, with no serious side effects or discomfort observed in the animals. Implantation (dosing) was completed in early January 2025. Absorption, distribution, metabolism, and excretion (ADME) testing is nearing completion, with final safety and pharmacokinetic reports anticipated 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 Pharma. "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."
SP-26 Design and Development
SP-26 is formulated as a ketamine-based injectable dissolvable polymer implant. The subcutaneous delivery system is designed to regulate dosage and time release of the pain-relieving treatment, potentially offering sustained relief. Silo Pharma is also collaborating with Kymanox to develop a specialized subcutaneous insertion device for SP-26, with the goal of optimizing tissue insertion depth and ensuring ease of use for at-home administration. Previous analytical testing has confirmed the optimal formulation for SP-26 implants.
Regulatory Pathway
If clinical trials are successful, SP-26 could qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval, potentially accelerating its availability to patients. Preclinical research has focused on aligning the safety profile of SP-26 with FDA requirements for potential at-home therapeutic designation.
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.
