Silo Pharma Announces Positive Results for Novel SPC-15 Treatment Targeting Stress-Related Disorders
Rhea-AI Summary
Silo Pharma (NASDAQ: SILO) announced positive preclinical study results for SPC-15, a novel dual-action treatment targeting stress-related disorders. The study combined SPC-15, a 5-HT4R agonist, with an NMDAR antagonist, demonstrating enhanced efficacy in treating stress-induced behaviors compared to single-agent treatments. The research showed significant improvements in behavioral outcomes related to severe stress-induced conditions in animal models. The company is developing SPC-15 as an intranasal prophylactic treatment for PTSD and plans to submit an IND for first-in-human trials.
Positive
- Preclinical study showed superior efficacy with dual-receptor targeting approach
- Demonstrated significant improvement in behavioral outcomes compared to single-agent treatments
- Advancing towards IND submission for human trials
Negative
- Still in early preclinical stage, far from commercialization
- Results to animal models, human efficacy yet to be proven
Insights
The preclinical results for SPC-15 represent a significant advancement in PTSD and depression treatment development. The dual-mechanism approach targeting both 5-HT4R and NMDAR pathways is particularly noteworthy, as current treatments typically focus on single pathways. The demonstrated superior efficacy of the combination versus monotherapy in animal models suggests potential for enhanced clinical outcomes.
However, investors should note several key considerations:
- This is still in preclinical stage - many promising preclinical candidates fail in human trials
- The path to IND filing and clinical trials will require substantial capital
- Market competition in PTSD/depression space is intense with multiple novel approaches under development
For a micro-cap biotech with
The focus on repurposing known compounds through novel delivery systems and combinations helps reduce development risk compared to entirely new chemical entities. Still, investors should recognize that commercialization is likely years away, requiring multiple successful trial phases and regulatory approvals.
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.
Key Study Findings
- 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.”
About SPC-15
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.
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 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.
Contact Information
800-705-0120
investors@silopharma.com
FAQ
What are the key findings of Silo Pharma's SPC-15 preclinical study?
What is the target indication for Silo Pharma's SPC-15 treatment?
What is the next development step for SILO's SPC-15?
