Silo Pharma Partners with AmplifyBio to Advance SPC-15 for PTSD and Anxiety
Silo Pharma (Nasdaq: SILO), a biopharmaceutical company, has partnered with AmplifyBio to conduct a GLP study for SPC-15, an intranasal treatment for PTSD and anxiety. This study aims to evaluate the safety and efficacy of SPC-15 over a 28-day period, following positive results from earlier non-GLP studies. The company's goal is to secure FDA approval for first-in-human trials. If successful, this will mark a significant milestone for Silo Pharma's development strategy.
- Partnership with AmplifyBio strengthens SPC-15 development.
- Positive results from non-GLP small animal studies.
- IND-enabling GLP study could lead to FDA approval for human trials.
- Pending FDA approval before human trials can commence.
Insights
In the biopharmaceutical sector, advancements in clinical trials are pivotal as they often signify potential growth trajectories. For Silo Pharma, the initiation of a large animal GLP (Good Laboratory Practice) study with AmplifyBio to further their lead asset, SPC-15, is a vital step. This study not only signifies progress but could also influence stock value as it brings the drug closer to human trials.
Financially, the successful completion of the GLP study enables Silo to seek U.S. FDA approval for first-in-human trials, a significant milestone that could potentially attract more investment and partnerships. Investors should note the importance of this study's success, as it could lead to increased valuation due to the expanded pipeline and potential market entry of SPC-15.
Additionally, Silo Pharma's consistent partnership with AmplifyBio since 2022 showcases stability and a strong foundation in their R&D approach, which is essential for long-term growth and investor confidence. However, it is important to remain cautious. The success of the preclinical study doesn't guarantee FDA approval or commercial success. Future financial statements and cash flow analysis should be monitored closely to understand Silo's ability to sustain its pipeline development.
The announcement of Silo Pharma's large animal GLP study for SPC-15 is a significant medical development. The drug, aimed at treating PTSD through an intranasal route, promises a unique mode of administration that could enhance patient adherence and outcomes compared to traditional oral or intravenous treatments.
From a medical perspective, the prior small animal studies showing rapid absorption and sustained exposure are encouraging. The shift to large animal studies is a critical phase that will provide more comprehensive data on the drug's safety and efficacy over a more extended period. This step is vital before moving to human trials, which are ultimately necessary to gauge the therapeutic potential in real-world scenarios.
However, it’s important to highlight that even if the GLP study shows positive results, there are still many hurdles to overcome before SPC-15 can be deemed a viable treatment option. Human trials come with their own sets of challenges, including patient variability and unforeseen side effects. The intranasal delivery method, while potentially innovative, will need rigorous testing to ensure consistency and reliability in human subjects.
For investors, understanding the market potential of SPC-15 is crucial. The focus on PTSD, a condition with significant prevalence and limited effective treatments, positions SPC-15 as a potentially high-impact drug if successful. PTSD affects about
From a market perspective, the development of a novel intranasal treatment could offer a competitive advantage, potentially capturing significant market share if it proves to be effective. The simplicity of a once-per-day dosing regimen might also enhance patient compliance compared to more complex treatment protocols. Given the ongoing mental health crisis, particularly post-pandemic, there is a heightened demand for innovative treatments and SPC-15 could meet this need.
However, investors should also consider the competitive landscape. Many companies are advancing PTSD treatments and the success of SPC-15 will depend on its differentiation from existing and pipeline therapies. Long-term market success will hinge on real-world efficacy, safety, price competitiveness and insurance coverage. Monitoring these factors will be essential to gauge SPC-15's commercial viability post-approval.
Amplify Bio to complete GLP study of SPC-15 Novel Intranasal Therapeutic
Silo study advances SPC-15 towards first-in-human trial
SARASOTA, FL, June 26, 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 awarded a contract to its contract research organization (CRO) partner AmplifyBio for an investigational new drug (IND)-enabling large animal GLP (Good Laboratory Practice) study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
The 4-week GLP study will evaluate a 28-day repeat intranasal dosing with a 14-day recovery. In a recent non-GLP small animal dose-ranging study conducted with AmplifyBio, SPC-15 demonstrated rapid absorption with good exposure over a 24-hour period, suggesting a simple once-per-day human intranasal dosing regimen. The Company entered into previous research and development agreements with AmplifyBio in early 2023 and 2022.
“Silo has partnered with AmplifyBio since 2022. Our longstanding collaboration has played a key role in advancing SPC-15 through multiple successful pre-clinical studies. A successful IND large animal GLP study is the final study that should facilitate seeking U.S. Food and Drug Administration (FDA) permission for first-in-human clinical studies in PTSD patients and would constitute a significant milestone achievement for the Company,” said Silo CEO Eric Weisblum.
Silo submitted a pre-IND briefing package and meeting request to the FDA for SPC-15 earlier this month. The IND-enabling GLP toxicology study is part of the final steps required before submission of an IND application to the FDA.
About SPC-15
SPC-15 an intranasal formulation administrated by a patented nose-to-brain device. The drug is a novel serotonin 4 (5-HT4) receptor agonist that utilizes biomarkers for the treatment of PTSD, anxiety, and other stress-induced affective disorders. 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 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 connect on social media at LinkedIn, X, and Facebook.
About AmplifyBio
AmplifyBio is a CRO integrating next-gen technologies to accelerate the development of safe, efficacious therapies. Characterization and manufacturing services combined with safety studies enhance product knowledge and mitigate risks. amplify-bio.com
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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