Silo Pharma’s Ketamine Implant Demonstrates Successful Drug Delivery

Silo Pharma, Inc. recently provided a positive update on SP-26, its novel time-released, dose-controlled formulation of ketamine initially targeted for fibromyalgia. A preclinical research study is underway involving analytical testing services and small batch proof-of-concept extrusion trials to determine drug release and stability.

In recent testing, SP-26 polymer implants were blended with ketamine hydrochloride (ketamine HCL) in two loadings, 20% and 40%. Measurements and analysis demonstrated that the drug was successfully loaded into the engineered particles to encapsulate the implantable treatment. The structural stability and integrity of both the 20% and 40% loaded implants were maintained, with no leakage, degradation, or discoloration.

“Implantable drug delivery systems like SP-26 may provide sustained drug delivery for prolonged periods of time, which is critical for the treatment of chronic pain conditions,” said Eric Weisblum, CEO of Silo. “We believe the initial testing provided sufficient validation of the delivery system for SP-26 and accordingly, our focus has shifted to testing of the ketamine formulation to measure drug dissolution and time-release action.”

Mr. Weisblum noted that conventional oral and injectable drugs typically provide peaks of concentration in blood followed by diminished concentration that falls outside of the therapeutic window. Silo believes implantable drug delivery systems (IDDS) can offer a superior delivery alternative for sustained relief from chronic pain.

Silo’s SP-26 is a ketamine-based injectable dissolvable 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.

Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The Company’s lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo’s research and development programs are conducted through collaborations with Columbia University and the University of Maryland, Baltimore. For more information, visit www.silopharma.com.