Silo Pharma set to Acquire Exclusive Licensing for Promising Alzheimer’s Disease Therapeutic
- None.
- None.
Insights
The exercise of an exclusive licensing agreement for a therapeutic candidate like SPC-14 by Silo Pharma from a prestigious institution such as Columbia University is a strategic move that can have significant financial implications. The Alzheimer's disease therapeutics market is rapidly expanding and a novel treatment like SPC-14 could position Silo Pharma advantageously within this sector. The market's forecasted growth to over $30.8 billion by 2033 indicates a substantial opportunity for revenue generation, particularly if the treatment can address the current inadequacies in AD care.
With the drug's potential eligibility for the FDA’s 505(b)(2) regulatory pathway, which often allows for a faster development process by enabling companies to rely on existing clinical data, Silo Pharma could see reduced development costs and a quicker time-to-market. This could result in a competitive edge and potentially early market penetration, assuming successful clinical trials and FDA approval. Investors should monitor Silo's progress closely, as milestones such as clinical trial results and regulatory approvals are critical value inflection points for the company's stock.
SPC-14’s reported cognitive improvement and stress reduction in preclinical models is noteworthy, especially in the context of Alzheimer's disease, where current treatment options are limited and focus primarily on symptom management rather than disease modification. The preclinical success of SPC-14 suggests a potential mechanism of action that may differ from existing therapies, which could lead to a paradigm shift in how Alzheimer's disease is treated.
It's important for stakeholders to understand that preclinical models are an early step in the drug development process and the translation of these results to human efficacy is uncertain. However, the licensing of SPC-14 reflects a level of confidence in its therapeutic potential. If subsequent clinical trials validate these preclinical findings, SPC-14 could meet a significant unmet need in the Alzheimer's market and offer a new treatment paradigm. The long-term implications for patients and the healthcare system could be profound, potentially altering the course of disease progression and improving quality of life for millions.
The consummation of an exclusive license agreement for a drug like SPC-14 has legal and strategic implications. The exclusivity of the license will prevent competitors from accessing this particular therapeutic candidate, allowing Silo Pharma to control the development, manufacturing and commercialization process of SPC-14 worldwide. This exclusivity is critical in the biopharmaceutical industry, as it ensures a period of market protection post-approval, during which Silo can recoup its investment and potentially realize significant profits.
From an intellectual property standpoint, the strength and scope of the patent rights licensed from Columbia University, as well as any additional patents Silo may file during development, will be essential in protecting the drug from generic competition. Investors should be aware that the value of Silo's stock will be influenced not only by the clinical and regulatory progress of SPC-14 but also by the robustness of its intellectual property portfolio.
SPC-14 shows cognitive and stress reduction benefits in preclinical models
SARASOTA, FL, April 10, 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 Alzheimer’s disease (AD) therapeutic SPC-14 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-14 worldwide upon consummation of such agreement. The Company expects to finalize and enter into the exclusive license agreement in the first half of 2024.
“Columbia University has discovered a therapeutic candidate that could bring relief and hope for Alzheimer’s patients and families,” said Eric Weisblum, CEO of Silo. “In our opinion, available treatments for AD remain largely inadequate. We believe that the cognitive improvement and stress reduction shown by SPC-14 in preclinical studies could hold promise for this underserved disease market.”
The global Alzheimer’s disease therapeutics market size is forecasted to exceed
Silo believes that SPC-14 should be eligible for development under the FDA’s 505(b)(2) regulatory pathway.
About SPC-14
Developed by Columbia University, SPC-14 is a novel therapeutic that targets glutamate receptor NDMAR and serotonin type 4 receptor 5HT4 to treat cognitive and neuropsychiatric symptoms in Alzheimer’s disease. In the latest small animal preclinical study, SPC-14 was effective against LH (luteinizing hormone) stress in attenuating learned helplessness, perseverative behavior, and hyponeophagia, a measure of anxiety.
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
1 Market.Us., Global Alzheimer’s Disease Therapeutics Market report, January 2024
FAQ
What is the latest announcement from Silo Pharma, Inc. regarding Alzheimer's disease?
What is the forecasted market size for Alzheimer's disease therapeutics by 2033?
What regulatory pathway does Silo Pharma, Inc. believe SPC-14 should be eligible for development under?
