Silo Pharma Exercises Option for Exclusive License Agreement for First-in-Class PTSD and Stress-Induced Anxiety Therapeutic
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Insights
The announcement by Silo Pharma regarding the exercise of its option to license SPC-15 marks a significant step in the company's pipeline development. With only two drugs currently approved for treating PTSD, the market is relatively underserved, providing a substantial opportunity for Silo. SPC-15's unique mechanism of action, which focuses on increasing stress resilience, could potentially offer a new therapeutic option for patients and differentiate it from existing treatments that primarily target depressive symptoms.
From an investment perspective, the progression of SPC-15 into pre-IND stages signals that the company is moving forward with its strategic priorities. However, it is essential to note that drug development is a long-term process with significant risks. The actual impact on the company's financials would be contingent on successful clinical trials, FDA approval and eventual market acceptance. Investors should monitor the upcoming pre-IND filing and subsequent clinical trial results for a clearer assessment of the drug's potential.
Considering the current therapeutic landscape for PTSD, Silo Pharma's focus on SPC-15 could address a notable gap in care. The company's strategic prioritization of this asset suggests confidence in its commercial viability. It is important for stakeholders to understand that the biopharmaceutical industry heavily invests in R&D and while the costs are high, the rewards can be significant if a drug is successful. The potential market size for a novel PTSD treatment is considerable, given the prevalence of the condition, particularly among military veterans.
Market adoption, however, will depend on the drug's efficacy, safety profile and cost-effectiveness compared to existing treatments. Moreover, the partnership with a reputable institution like Columbia University could lend credibility to the research and development process, possibly impacting investor sentiment positively. Nonetheless, the actual commercial impact would only materialize post-regulatory approvals, which is a critical aspect for investors to consider.
The transition of SPC-15 into the pre-IND phase is a critical juncture in clinical development. The fact that Silo Pharma has observed consistently strong data in pre-clinical studies is promising, yet these results must be interpreted with caution. Pre-clinical success does not guarantee similar outcomes in human trials. The effectiveness and safety in a broader population will be scrutinized in the upcoming clinical trials.
For SPC-15, the focus on stress-induced affective disorders, including anxiety and PTSD, could potentially meet an unmet medical need. However, the drug's success will heavily rely on the design and execution of these trials. Rigorous trial design, patient selection and endpoint determination will be important in determining the drug's fate. The clinical trial results will not only shape the drug's regulatory pathway but also influence investor confidence and the company's stock performance.
Exclusive license for development, manufacturing, and commercialization in process
Silo Pharma to file Pre-IND in first half 2024
SARASOTA, FL, March 20, 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 that it has exercised its option to license SPC-15, a prophylactic treatment for stress-induced affective disorders including anxiety and PTSD, from Columbia University, pursuant to a sponsored research and option agreement established in 2021. Under the terms of the license agreement currently in process, Silo will be granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide. The Company expects to finalize and enter into the exclusive license agreement in the first half of 2024.
“Through our research collaboration with Columbia University and our CRO studies, we have successfully taken SPC-15 through pre-clinical development to prepare for the submission of our FDA pre-investigational New Drug Application (IND) by the end of the second quarter 2024,” said Eric Weisblum, CEO of Silo. “In each study, we have observed consistently strong data which we believe warrants the exercise of our option for exclusive worldwide licensing rights for this novel drug candidate.”
Only two drugs are currently approved for treating PTSD, both of which target only the depressive effects of the condition. In contrast, SPC-15’s differentiated method of action is designed to increase stress resilience in high-risk populations. Silo has identified clinical development of lead asset SPC-15 as the Company’s top strategic priority in 2024.
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 under a sponsored research agreement and option.
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
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investors@silopharma.com
FAQ
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