EXCLUSIVE: Silo Pharma's Investigational Ketamine Implant Hits All Endpoints In Pain Study In Animal Models

Silo Pharma, Inc. SILO on Wednesday released results for its preclinical study evaluating SP-26.

SP-26 is a ketamine-based injectable dissolvable polymer implant for chronic pain and fibromyalgia. If clinically successful, SP-26 could qualify for the FDA's streamlined 505(b)(2) regulatory pathway for drug approval.

The study met all endpoints, including survival, clinical observations, body weight stability, neurological assessments, and histopathological evaluation.

The study, which was conducted in minipigs, evaluated the pharmacokinetics, safety, and local tolerability of SP-26 formulations when administered subcutaneously.

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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.

"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," commented Eric Weisblum, CEO of Silo Pharma. "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."

Study Highlights:

Safety Profile: No implant-related adverse events were observed. To the study conclusion, animals maintained a healthy weight, normal neurological behavior, and full survival.
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 minimal to mild chronic inflammation at the implant sites, with no dose-dependent or formulation-specific differences.

On Monday, Silo Pharma filed a patent application with the U.S. Patent and Trademark Office (USPTO) focused on the neurology drug SPC-14, an intranasal compound for Alzheimer's disease exclusively licensed to Silo Pharma from Columbia University.

Price Action: SILO stock is up 3.72% at $0.84 during the premarket session at the last check Wednesday.

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