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Silo Pharma Announces Positive Results for Novel SPC-15 Treatment Targeting Stress-Related Disorders

Key Takeaway: Silo Pharma, Inc. has announced positive preclinical study results for its novel treatment SPC-15, which targets stress-related disorders such as PTSD. The dual-action approach, combining a 5-HT4 receptor agonist with an NMDA receptor antagonist, showed marked improvements in managing severe stress-induced behaviors in animal models. The company is advancing its development with plans for an IND submission for human trials. If successful, SPC-15 could qualify for FDA's streamlined approval pathway.

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POSITIVE FACTORS

  • Promising results from preclinical studies for SPC-15 treatment.
  • Dual-target approach shows enhanced efficacy for severe stress-related conditions.
  • Potential to provide effective treatment for patients with treatment-resistant depression.
  • Advancement towards an IND submission for first-in-human trials.

Full Press Release Details

Dual-action approach combining 5-HT4R Agonist (SPC-15) and NMDAR antagonist demonstrates enhanced efficacy in preclinical study for managing severe conditions
The Company is currently developing SPC-15 as an intranasal treatment for PTSD
SARASOTA, FL, Nov. 18, 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 promising results from a preclinical study on SPC-15. This new formulation, which targets both the serotonin 5-HT4 receptor (5-HT4R) and the NMDA receptor (NMDAR), has shown potential as a treatment for major depressive disorder (MDD), and other severe stress-related conditions.
The study highlights the proposed efficacy of combining SPC-15, a 5-HT4R agonist, with an NMDAR antagonist to treat stress-induced behaviors. Results from animal models indicate that this dual-target approach may offer additional efficacy in treating severe conditions compared to using either agent alone, suggesting a potential enhanced therapeutic effect for managing severe psychiatric conditions.
Dual Receptor Targeting Yields Superior Results: By simultaneously targeting 5-HT4R and NMDAR, the combined treatment demonstrated significant improvement in behavioral outcomes related to severe stress-induced conditions as compared to using either agent alone.
Additive Therapeutic Effects: The combination therapy showed a marked reduction in stress behaviors in animal models, indicating potential benefits for patients suffering from treatment-resistant depression.
“We are encouraged by these results, which point to what we believe is a promising new approach for managing severe stress-related psychiatric disorders,” said Eric Weisblum, CEO of Silo Pharma. “In our opinion, our dual-action strategy with SPC-15 demonstrates the potential to provide an effective treatment option for patients experiencing severe and relapsed stress-related disorders.
“We believe these findings further support our continuing development of SPC-15 as an intranasal prophylactic treatment for PTSD,” Weisblum added. “We are advancing this program with a goal of an IND submission for first-in-human trials.”
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist that utilizes biomarkers for the treatment of PTSD, anxiety, and other stress-induced affective disorders. SPC-15 is being developed as an intranasal medication. If clinically successful, SPC-15 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Silo Pharma is conducting preclinical studies of SPC-15 in collaboration with Columbia University and was granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
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 follow Silo Pharma on 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 SPC-15 developed for?

SPC-15 is being developed as an intranasal treatment for PTSD.

How does SPC-15 work?

SPC-15 targets both the serotonin 5-HT4 receptor and NMDA receptor.

What were the results of the preclinical study?

The study showed enhanced efficacy in treating stress-induced behaviors.

What conditions can SPC-15 potentially treat?

It may treat major depressive disorder and other stress-related conditions.

How is Silo Pharma advancing SPC-15?

They aim for an IND submission for first-in-human trials.

Last updated: Nov 18, 2024