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Silo Pharma Announces Positive Results from Study for Depression Treatment, Remission, and Relapse Prevention

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Silo Pharma announced promising results from a study on depression treatment and relapse prevention. This study, in collaboration with Columbia University, identified a new drug formulation that significantly improves mood stability without common side effects of current antidepressants. CEO Eric Weisblum emphasized the potential impact on millions suffering from depression. Additionally, Silo is advancing its SPC-15 program for PTSD, with plans to submit a pre-IND to the FDA. The company is finalizing an exclusive license agreement to develop and commercialize SPC-15 globally, expected to complete in the first half of 2024.

Positive
  • New drug formulation shows promising mood stability improvements without common side effects.
  • Potential to significantly impact depression treatment, addressing a large patient population.
  • Advancement of SPC-15 program for PTSD, moving towards FDA pre-IND submission.
  • Exclusive license agreement with Columbia University for SPC-15 development and commercialization.
Negative
  • Unclear how long it will take for the new drug formulation to reach the market.
  • Potential risks associated with transitioning from pre-clinical to clinical trials.
  • Dependence on successful finalization of the license agreement with Columbia University.

Insights

Silo Pharma’s new results in their depression treatment study indicate a potentially groundbreaking development in the field of psychiatry and pharmacology. Unlike existing antidepressants, which often come with significant side effects and variable efficacy, the new formulation targets novel biochemical pathways related to mood regulation. This could offer more stable mood improvements without the typical adverse effects. Crucially, the data suggest prolonged remission periods and relapse prevention, which are significant hurdles in current depression therapies.

From a medical perspective, this innovation could drastically improve the quality of life for patients with depression. However, it’s important to note that these results are preliminary and further validation through clinical trials is essential. The unique approach to targeting unexplored biochemical pathways also presents potential risks due to the limited understanding of these pathways in the context of depression. Stakeholders should remain cautiously optimistic until more comprehensive data is available.

The positive outcomes from Silo Pharma’s research could have substantial financial implications for the company. If the new drug formulation successfully navigates through clinical trials and gains FDA approval, it could potentially tap into the multi-billion-dollar antidepressant market. The company's decision to license SPC-15 from Columbia University and its advancement to pre-IND application stage underscores a robust pipeline strategy aimed at diversifying its portfolio beyond PTSD treatment.

However, investors should consider the inherent financial risks associated with developmental stage biopharmaceutical companies, such as high R&D costs, regulatory hurdles and market competition. While the reported results are promising, it’s vital to monitor subsequent trial phases and regulatory updates closely. Short-term volatility in stock prices is possible, but the long-term potential of this innovative treatment could drive significant growth if successfully commercialized.

The depression treatment market is highly competitive, with numerous established players like Eli Lilly and Pfizer. Silo Pharma’s novel drug formulation targeting unexplored biochemical pathways could distinguish it from existing medications. The reported efficacy in mood stabilization and reduced side effects positions it as a potentially disruptive player in the market.

From a market dynamics perspective, the successful development and commercialization of this new treatment could shift market share towards Silo Pharma, particularly if they can demonstrate superior efficacy and safety profiles in large-scale clinical trials. Additionally, the global rise in mental health awareness and treatment demand provides a favorable market environment for new and effective therapies. However, market penetration will also depend on pricing, marketing strategies and insurance coverage, which are yet to be detailed by the company.

The study has identified a potentially new drug formulation that could potentially extend the period of remission and prevent relapse in patients with depression.

SARASOTA, FL, May 21, 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 new results in its research focused on depression remission and relapse prevention.

A recent study under the Company’s sponsored research agreement with Columbia University suggested a potentially innovative drug formulation that targets biochemical pathways associated with mood regulation previously unexplored by the Company which showed positive effects including marked improvements in patient mood stability without the side effects commonly associated with existing antidepressants.

“The recently completed study demonstrated marked improvements in mood stability, which we see as a potentially significant development for combatting depression and preventing relapse,” said Silo CEO Eric Weisblum. “While advancing our SPC-15 program in PTSD to the clinic remains our top pipeline priority, we are excited about these encouraging new results and the additional potential for treating millions of people affected by depression which could ultimately expand our pipeline.”

Silo has successfully taken SPC-15 through pre-clinical development and is preparing to submit a pre-investigational New Drug Application (IND) to the FDA for the drug’s lead indication in PTSD. Silo has exercised its option to license SPC-15 from Columbia University, pursuant to a sponsored research and option agreement originally established in 2021. Under the terms of the license agreement, which is currently being finalized, Silo will be granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide. The Company expects to complete and enter into the exclusive license agreement in the first half of 2024.

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.

Contact 

800-705-0120 
investors@silopharma.com


FAQ

What are the latest results from Silo Pharma's study on depression?

Silo Pharma's study identified a new drug formulation that significantly improves mood stability without the side effects commonly associated with current antidepressants.

When did Silo Pharma announce the results of its depression study?

Silo Pharma announced the results on May 21, 2024.

What is the impact of Silo Pharma's new drug formulation for depression?

The new formulation could extend remission periods and prevent relapse in patients with depression, potentially benefiting millions.

What is Silo Pharma's SPC-15 program?

SPC-15 is a drug program targeting PTSD, which has successfully completed pre-clinical development and is moving towards a pre-IND submission to the FDA.

What are the terms of the license agreement between Silo Pharma and Columbia University?

The agreement grants Silo an exclusive license to develop, manufacture, and commercialize SPC-15 worldwide, expected to be finalized in the first half of 2024.

What are the risks associated with Silo Pharma's new drug development?

Risks include the time required to bring the new drug to market and potential challenges in transitioning from pre-clinical to clinical trials.

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