Silo Pharma Completes Successful Dose-Ranging Study of SPC-15 Intranasal Therapeutic for PTSD
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Insights
The pharmacokinetic profile of a drug is paramount in determining its dosing regimen. The data suggesting rapid absorption and good exposure of SPC-15 over a 24-hour period is indicative of a drug with the potential for convenient dosing, which can significantly enhance patient adherence, particularly in conditions like anxiety and PTSD where consistent medication levels are crucial for therapeutic effectiveness. The maximum tolerated dose establishes a safety threshold, which is essential before proceeding to human trials. The pharmacological community will be keenly observing the transition from non-GLP to GLP studies and eventually to the IND submission, as these are critical milestones in drug development.
From a research perspective, the positive results from Silo Pharma's non-GLP study are promising, yet investors should be cautious. The leap from small animal studies to human clinical trials is significant and fraught with uncertainties. The therapeutic domain of anxiety and PTSD is highly competitive, with a number of established treatments available. The potential market penetration of SPC-15 will depend on its efficacy, safety and cost-effectiveness compared to current standards of care. Additionally, the company's timeline for the pre-IND submission is a critical factor that will be closely monitored by stakeholders.
Investors in the biopharmaceutical sector closely track the progress of drug development pipelines. Silo Pharma's announcement could influence its market valuation, with the caveat that the drug is still in early stages of development. The focus on novel formulations and drug delivery systems, particularly in the burgeoning field of psychedelic treatments, could position Silo favorably in a niche but rapidly growing market. However, the long-term success and impact on the stock market will hinge on subsequent clinical trial outcomes and the ability to navigate the regulatory landscape.
All animal subjects tolerated maximum dosing
Once-per-day human intranasal dosing regimen determined for clinical evaluation
SARASOTA, FL, Feb. 28, 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 results from its non-GLP small animal dose-ranging study of SPC-15, an intranasal prophylactic treatment for anxiety and post-traumatic stress disorder (PTSD).
The purpose of the non-GLP small animal study was to identify the maximum tolerated intranasal dose of the drug pharmacokinetic and determine the therapeutically relevant dose range to be studied in clinical trials. Data analysis demonstrated rapid absorption of SPC-15 with good exposure over a 24-hour period, suggesting a once-per-day human intranasal dosing regimen would be optimal.
“Non-GLP and GLP toxicology and safety pharmacology studies are required steps before seeking approval for our first-in-human clinical-stage trials of SPC-15,” said Eric Weisblum, CEO of Silo. “We are currently on track to submit a pre-investigational New Drug Application (IND) to the FDA by the end of the second quarter 2024. This is an exciting step forward for our Company as we advance our lead therapeutic, SPC-15.”
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.
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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FAQ
What is the purpose of the non-GLP small animal dose-ranging study conducted by Silo Pharma, Inc. regarding SPC-15?
What dosing regimen was determined for human clinical evaluation based on the study results?
When does Silo Pharma, Inc. plan to submit a pre-IND application to the FDA?
What type of therapeutic is SPC-15 being developed as by Silo Pharma, Inc.?
