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Silo Pharma’s SP-26 Ketamine Implant Demonstrates Successful Drug Delivery

Key Takeaway: Silo Pharma announced a positive update on their SP-26 ketamine implant, designed for chronic pain and fibromyalgia treatment. Recent testing has confirmed the successful loading of ketamine into the implants while maintaining structural integrity. The company believes that this implantable drug delivery system could offer sustained relief for chronic conditions, potentially qualifying for an expedited FDA approval. Silo plans to progress into further testing of the ketamine formulation to assess its release and effectiveness.

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POSITIVE FACTORS

  • Successful loading and stability of SP-26 ketamine implants demonstrated.
  • Potential for sustained drug delivery for chronic pain management.
  • Focus on FDA's 505(b)(2) regulatory pathway could expedite approval.

Full Press Release Details

Initial indications target fibromyalgia and chronic pain
Loaded and encapsulated drug maintains structural stability as implantable treatment
SARASOTA, FL, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today provided a positive update on SP-26, its novel time-released, dose-controlled formulation of ketamine initially targeted for fibromyalgia. A pre-clinical 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 that 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 and connect on social media at LinkedIn, X, and Facebook.
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 by the use of 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 presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.

Frequently Asked Questions

What is SP-26 targeted for?

SP-26 is initially targeted for fibromyalgia and chronic pain treatment.

What type of drug delivery system is SP-26?

SP-26 is an implantable drug delivery system for sustained drug release.

What are the loading percentages tested for SP-26?

SP-26 was tested with 20% and 40% loadings of ketamine hydrochloride.

What therapeutic pathway could SP-26 qualify for?

SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway.

What are Silo Pharma's main areas of focus?

Silo Pharma focuses on chronic pain, psychiatric disorders, and CNS diseases.

Last updated: Feb 14, 2024