Silo Pharma Secures Exclusive Global License for Alzheimer's Therapeutic
Silo Pharma (Nasdaq: SILO) has secured an exclusive global license for SPC-14, an Alzheimer's therapeutic. The company plans to use the FDA's 505(b)(2) pathway for expedited development. CEO Eric Weisblum believes SPC-14 could address a significant unmet medical need, with early pre-clinical studies showing stress reduction and cognitive improvement. This agreement follows a similar license for SPC-15, an intranasal treatment for stress-induced affective disorders and PTSD.
The global Alzheimer's disease therapeutics market is projected to exceed $30.8 billion by 2033, with a CAGR of 18.8% from 2024 to 2033. Market growth is expected to be driven by the increasing prevalence of Alzheimer's in the aging population and advancements in neurological research.
- Secured exclusive global license for Alzheimer's therapeutic SPC-14
- Plans to use FDA's 505(b)(2) pathway for faster and cheaper drug development
- Early pre-clinical studies show stress reduction and cognitive improvement
- Global Alzheimer's therapeutics market projected to exceed $30.8 billion by 2033
- High market growth potential with 18.8% CAGR from 2024 to 2033
- None.
Insights
Silo Pharma's recent announcement of securing an exclusive global license for SPC-14 adds a potentially valuable asset to its portfolio. By aiming to use the FDA's 505(b)(2) pathway, Silo might benefit from a faster, more cost-effective route to market. This is significant because the 505(b)(2) pathway allows companies to use existing clinical data, which could significantly shorten the time required for approval and reduce development costs. For investors, the expedited process translates to potentially quicker returns and reduced risk compared to traditional new drug applications.
However, it is essential to note that while pre-clinical studies are promising, SPC-14 must still undergo rigorous clinical trials to prove its efficacy and safety. This introduces inherent uncertainty and risk. Additionally, the market for Alzheimer’s therapies is highly competitive, with numerous companies striving to address this $30.8 billion market. Investors should be aware of the potential for dilution of market share and the challenges of differentiating SPC-14 from existing and future treatments.
In the short term, Silo Pharma's move could boost investor sentiment and share price due to the perceived potential and strategic positioning. Long-term success will hinge on clinical trial outcomes and the company’s ability to navigate regulatory pathways efficiently.
The exclusive license for SPC-14, aimed at Alzheimer's treatment, represents a significant step for Silo Pharma. Alzheimer's disease is a rapidly growing concern given the aging global population and any advancement in this field garners attention. The mention of early pre-clinical studies showing stress reduction and cognitive improvement is promising, but these findings need to be validated through comprehensive clinical trials. The medical community is cautiously optimistic about new treatments due to the complexity of the disease and the high failure rate of previous attempts.
SPC-14's future hinges on successful clinical trials, which must demonstrate not just safety but also meaningful cognitive benefits. The pathway chosen, 505(b)(2), is advantageous as it typically involves fewer and smaller trials compared to traditional pathways. This can potentially reduce time to market and lower costs. However, given the high stakes involved in treating Alzheimer's, regulatory bodies will meticulously scrutinize the data.
For investors, understanding the clinical trial phases and milestones will be crucial. Early successes in trials could act as strong positive catalysts, while setbacks could impact stock negatively. A detailed follow-up on trial progress and peer comparisons will be essential to gauge SPC-14's potential impact.
Agreement enhances Company’s intellectual property portfolio
SARASOTA, FL, July 16, 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 entered into an exclusive global license agreement to further develop, manufacture, and commercialize its Alzheimer’s drug SPC-14. Silo intends to utilize the FDA’s streamlined 505(b)(2) pathway for SPC-14, which would shorten clinical timelines and reduce drug development costs.
“In our view, our exclusive license for SPC-14 gives us the potential to meet a large unmet medical need. If approved, we believe SPC-14 could bring hope and relief for many families and patients. Early pre-clinical studies have shown stress reduction and cognitive improvement,” said Silo CEO Eric Weisblum.
Silo Pharma recently announced a similar exclusive license agreement for its lead drug candidate, SPC-15, an intranasal treatment for stress-induced affective disorders and PTSD.
The global Alzheimer’s disease therapeutics market size is forecasted to exceed
About SPC-14
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.
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 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
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