Analytical testing has confirmed optimal formulation for upcoming studies
SARASOTA, FL, June 07, 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 announced a successful series of development activities for the Company’s SP-26 ketamine implant therapeutic targeting fibromyalgia and chronic pain.
An ongoing pre-clinical research study of SP-26 is underway involving analytical testing services and small batch proof-of-concept extrusion trials for the ketamine hydrochloride (ketamine HCL) implants at 20% and 40% drug load.
The Company previously reported that the initial testing provided validation of the delivery system based on measures of structural stability and integrity at both load levels. Following those tests, a series of manufacturing studies were conducted using three different bioresorbable polymers. The assay testing revealed positive data for inherent viscosity (IV), blend uniformity (BU), and dissolution of the implants:
- IV results were within the expected range for drug delivery of the active ingredient, and higher for the combined formulation with ketamine
- The sample results met FDA guidelines for an adequate level of blending
- The larger implants showed faster dissolution time
Silo CEO, Eric Weisblum commented, “The results so far in our ongoing SP-26 pre-clinical research bring us closer to determining the optimal formulation for future pre-clinical testing models. We are pleased with the structural stability, integrity, and functionality observed to date for our innovative non-opioid chronic pain therapeutic.”
About SP-26
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.
About Silo Pharma
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.
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