Silo Pharma Announces Positive Results for Intranasal PTSD Treatment

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Silo Pharma, Inc. (Nasdaq: SILO) announces positive data for intranasal PTSD treatment SPC-15, showing rapid absorption and consistent exposure. The PK study results indicate effective drug administration. CEO Eric Weisblum believes the results will translate well to humans, paving the way for further clinical studies and FDA application in 2024.

Positive

• Positive data in the final validation report from the recent pharmacokinetic (PK) study of SPC-15
• Rapid absorption of SPC-15 with good exposure over a 24-hour period
• Effective and consistent exposure from intranasal administration of the drug
• Optimal once-per-day human intranasal dosing determined
• Progressive intellectual and neurological deterioration (PIND) study and GLP study scheduled for 2024
• Steps towards submission of an Investigational New Drug (IND) application for SPC-15 to the FDA

Negative

• None.

Pharmacology Expert

The pharmacokinetics (PK) of a drug, including absorption, distribution, metabolism and excretion, are pivotal in determining its efficacy and safety profile. The reported rapid Tmax for SPC-15 suggests a quick onset of action, which can be a significant advantage in treating acute anxiety episodes associated with PTSD. However, it's important for investors to understand that the transition from animal PK data to human clinical data is not always linear. The mention of progressing to a PIND study indicates Silo Pharma's commitment to comprehensively examine the neurological implications before moving on to GLP studies required for FDA IND submissions. This meticulous approach could increase the likelihood of a positive regulatory outcome but also extends the timeline before potential market entry.

Biotech Market Analyst

Entering the PTSD treatment market with an intranasal therapy could be a strategic move for Silo Pharma, given the preference for non-invasive administration routes. The market for PTSD treatments is evolving and therapies that offer rapid relief are particularly appealing. If human trials reflect the positive PK data from animal studies, Silo could capture significant market interest. However, investors should note that the biotech sector is known for volatility, especially in the developmental stages. While the CEO expresses confidence, the actual replication of these results in human trials is a critical milestone that will influence the company's valuation and investor sentiment.

Financial Analyst

The announcement of positive results from a pharmacokinetic study for a potential PTSD treatment can influence the company's stock. The ability to define an optimal once-per-day human dose is financially advantageous, possibly resulting in a competitive pricing strategy and patient adherence. However, it's important for investors to remain cautious, as further studies, regulatory approvals and market acceptance are necessary before any potential revenue from SPC-15 can materialize. Investors should pay attention to the company's cash burn rate and subsequent funding requirements as these studies advance, as they may lead to dilutive financing or partnership agreements.

Intranasal Delivery of SPC-15 shows rapid and effective drug exposure for PTSD Therapy

SARASOTA, FL, April 23, 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 positive data in the final validation report from the recent pharmacokinetic (PK) study

of SPC-15, an intranasal prophylactic treatment for anxiety and post-traumatic stress disorder (PTSD). The PK study was conducted as part of non-GLP small animal dose-ranging study of SPC-15 completed in February 2024.

The activity of SPC-15 in the subjects or the PK study was evaluated over a 7-day repeat intranasal dose, including the processes of absorption, distribution, and excretion. Time to peak drug concentration (T_max) occurred between 0.5 and 2 hours following intranasal administration compared to 2 hours following oral gavage administration. In previous findings from the non-GLP study, SPC-15 demonstrated rapid absorption with good exposure over a full 24-hour period, and based on these studies we determined an optimal once-per-day human intranasal dosing.

Silo CEO Eric Weisblum commented, “Our evaluation of the PK profile for SPC-15 indicates effective and consistent exposure from intranasal administration of the drug. We believe these study results will be substantially replicated in humans.” 

Now completed, the non-GLP study will be followed by a progressive intellectual and neurological deterioration (PIND) study and then a GLP study, both slated to commence in 2024, and both of which are additional required steps before submission of an Investigational New Drug (IND) application for SPC-15 to the FDA.

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 
800-705-0120 
investors@silopharma.com

FAQ

What is the ticker symbol for Silo Pharma, Inc.?

The ticker symbol for Silo Pharma, Inc. is SILO.

What positive results were announced by Silo Pharma for the intranasal PTSD treatment?

Silo Pharma announced positive data in the final validation report from the recent pharmacokinetic (PK) study of SPC-15, showing rapid absorption and consistent exposure.

Who commented on the evaluation of the PK profile for SPC-15?

CEO Eric Weisblum commented on the evaluation of the PK profile for SPC-15, indicating effective and consistent exposure from intranasal administration of the drug.

What are the next steps after the non-GLP study for SPC-15?

The next steps include a progressive intellectual and neurological deterioration (PIND) study and a GLP study, both scheduled to commence in 2024, before submission of an Investigational New Drug (IND) application for SPC-15 to the FDA.