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Silo Pharma Enters Joint Development Agreement for SP-26 Ketamine Implant Device Targeting Pain Management

Key Takeaway: Silo Pharma has entered into a joint development agreement with Kymanox to create a subcutaneous insertion device for its ketamine-loaded implant, SP-26, targeting fibromyalgia and chronic pain. The collaboration will focus on the proof-of-concept and prototype testing of the device to ensure optimal insertion depth. SP-26 aims to provide sustained pain relief and, if successful, could qualify for the FDA's streamlined approval pathway for at-home therapies. This initiative marks a significant step forward in Silo's efforts to develop novel pain management solutions.

Market Sentiment Analysis

POSITIVE FACTORS

  • Collaboration with Kymanox for specialized design of SP-26 device.
  • Development of a novel ketamine implant aimed at chronic pain management.
  • Potential FDA approval of SP-26 for at-home injectable therapeutic use.
  • Progress in preclinical studies indicating a favorable safety profile.

CONCERNS & RISKS

  • Dependence on successful preclinical testing outcomes.
  • Potential regulatory challenges in obtaining FDA approval.
  • Uncertainties related to the timelines of product development.

Full Press Release Details

Prototype development and feasibility testing underway for optimized subcutaneous delivery
SARASOTA, FL, Nov. 29, 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 collaboration agreement with Kymanox for specialized design and development of a subcutaneous insertion device for SP-26, the Company’s ketamine-loaded implant therapeutic targeting fibromyalgia and chronic pain.
Under terms of the agreement, Kymanox will conduct an initial proof-of-concept design phase followed by full system prototype and feasibility testing to determine optimal insertion depth in tissue.
“Previous analytical testing and proof-of-concept extrusion trials have confirmed the optimal formulation for our SP-26 implants. Now we are advancing this program to develop a novel insertion device that is intended to be tested in continuing preclinical studies,” said Silo CEO Eric Weisblum. “We are pleased with the steady progress we are making with our proposed ketamine implants, which are being uniquely designed with a goal of providing sustained relief of chronic pain.”
Preclinical research to date has focused, in part, 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.
In addition to the SP-26 agreement, Kymanox is Silo’s regulatory partner for SPC-15, a targeted prophylactic treatment for stress-induced affective disorders including PTSD.
Silo’s SP-26 is a ketamine-based injectable dissolvable polymer 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 universities and independent laboratories. 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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Frequently Asked Questions

What is SP-26 developed by Silo Pharma?

SP-26 is a ketamine-based implant designed for chronic pain and fibromyalgia relief.

What is the role of Kymanox in SP-26 development?

Kymanox will design and develop the subcutaneous insertion device for SP-26.

How does SP-26 deliver pain relief?

SP-26 is a time-release implant that regulates dosage and delivers sustained relief.

What is the aim of Silo Pharma's research?

Silo aims to develop novel therapeutics for chronic pain and stress-related disorders.

Could SP-26 qualify for FDA's expedited approval?

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

Last updated: Nov 29, 2024