Silo Pharma's SP-26

Silo Pharma's SP-26 Implant Achieves All Endpoints In Preclinical Fibromyalgia Study

Silo Pharma, Inc., a developmental-stage biopharmaceutical company focused on innovative therapies for chronic pain and CNS disorders, has reported positive preclinical results for its lead asset SP-26, an extended-release ketamine implant designed for the treatment of fibromyalgia.

SP-26 is a subcutaneous, long-acting polymer implant that delivers controlled, sub-psychedelic levels of ketamine, potentially offering a safe and convenient alternative to traditional opioid-based therapies.

The preclinical study, conducted in minipigs, met all primary endpoints, including safety, tolerability, sustained drug release, and neurological assessments—key indicators that support advancement toward human trials. Notably, SP-26 maintained therapeutic ketamine levels for up to 22 days, with peak plasma concentrations reached within one hour of administration.

The implant showed no adverse safety signals, and animals maintained stable body weight and normal neurological function throughout the study duration. Minimal local tissue reaction was observed, and there were no dose-related differences in tolerability, suggesting a favorable safety profile.

The implant's extended-release mechanism also helps reduce risks associated with IV ketamine infusions, such as dissociation.

Silo aims to pursue clinical development of SP-26 through the FDA's streamlined 505(b)(2) regulatory pathway, with hopes of ultimately positioning the therapy as the first at-home injectable ketamine-based treatment for fibromyalgia.

In addition to SP-26, Silo's pipeline includes assets for PTSD, Alzheimer's disease, and multiple sclerosis, further reflecting the company's commitment to developing novel solutions for underserved neurological and pain-related conditions.

Currently, SILO is trading at $0.73 down by 9.75 percent on the Nasdaq.