Silo Pharma Submits Pre-Investigational New Drug Application to FDA for SPC-15 as a Treatment for PTSD and Anxiety
Silo Pharma has submitted a pre-Investigational New Drug (pre-IND) application to the FDA for SPC-15, its intranasal treatment for PTSD and anxiety. The application seeks guidance for initiating first-in-human trials. Preclinical studies show positive results, with effective intranasal delivery in animal models. Silo expects to finalize an exclusive license agreement with Columbia University for SPC-15 by mid-2024. The company plans further studies in 2024, essential for future IND submission. SPC-15 aims to enhance stress resilience, differing from existing PTSD treatments that mainly address depressive symptoms.
- Silo Pharma has successfully submitted a pre-IND application to the FDA for SPC-15.
- Positive preclinical data shows effective and consistent intranasal delivery in small animal studies.
- Silo to finalize an exclusive license agreement with Columbia University by mid-2024.
- SPC-15 aims to increase stress resilience, offering a novel approach compared to current PTSD treatments.
- The company plans a PIND and a GLP study in the second half of 2024, advancing towards IND submission.
- The studies for SPC-15 are still in the preclinical phase, meaning significant time before potential market entry.
- Pending FDA guidance and future study results introduce uncertainty and potential delays.
- No revenue is currently generated from SPC-15, posing financial risks for investors.
Insights
The submission of a pre-IND application to the FDA by Silo Pharma marks a significant milestone in the development of SPC-15, a novel intranasal treatment for PTSD and anxiety. This step is important as it sets the stage for formal discussions with the FDA and provides guidance for the future clinical trials. With only two FDA-approved drugs for PTSD, the introduction of SPC-15 could fill an unmet need, particularly given its unique mechanism aimed at enhancing stress resilience. This is particularly relevant for high-risk populations where current treatment options might not be fully effective.
Preclinical data shows promise, with SPC-15 demonstrating consistent exposure and effectiveness in small animal models. However, it's important to note that these results, although encouraging, are still early-stage. The upcoming GLP study and PIND study will be critical in determining whether these preclinical successes can be replicated in humans. Investors should be mindful of the timeline and inherent risks associated with drug development, especially in the early phases.
The collaboration with Columbia University further strengthens Silo Pharma's position. The forthcoming exclusive license agreement could offer advantages in terms of research support and commercialization strategies. However, the actual impact will depend on the results of the impending clinical trials and the subsequent approval process.
From a market perspective, Silo Pharma’s entry into the PTSD treatment space is noteworthy. The existing market for PTSD treatments is limited, dominated by only two approved drugs, which primarily target depression. SPC-15, with its distinct mechanism to enhance stress resilience, could potentially carve out a niche market segment. If successful, it could cater to patients who do not respond well to current therapies, thereby expanding the addressable market.
Investors should consider the competitive landscape and the potential market size for PTSD treatments. Given the rising awareness and diagnosis of PTSD, as well as the significant needs of the affected population, the financial prospects for a new, effective treatment could be substantial. However, the success of SPC-15 will hinge on multiple factors including the results of human trials, FDA approval and effective commercialization strategies.
Clinical roadmap unveiled for novel and proprietary intranasal PTSD treatment
SARASOTA, FL, June 04, 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 its submission of a pre-Investigational New Drug (pre-IND) briefing package and meeting request to the U.S. Food and Drug Administration (FDA) for SPC-15, Silo’s intranasal prophylactic treatment for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder.
Pre-clinical data indicate that SPC-15 has additive benefits for combating stress-induced pathophysiology, both at the behavioral and neural levels. The Company recently announced positive results, including effective and consistent exposure from intranasal administration of SPC-15, from a non-GLP (good laboratory practice) small animal dose-ranging study completed in February 2024. In accordance with a sponsored research agreement with Columbia University, 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.
Silo CEO Eric Weisblum commented, “We believe our preclinical work on SPC-15, supported by published preclinical data, provides a strong foundation for our development strategies and initial clinical trial design. We anticipate that our pre-IND submission will lead to valuable guidance from the FDA as we prepare for the first-in-human clinical trial of SPC-15 in PTSD.”
Next steps for Silo’s SPC-15 program include a progressive intellectual and neurological deterioration (PIND) study followed by a GLP study, both slated to commence in the second half of 2024. Both studies are required steps before submission of an Investigational New Drug (IND) application to the FDA.
Only two drugs are currently approved by the FDA for treating PTSD, both of which primarily target 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.
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.
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
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