Silo Pharma Successfully Completes First Phase of Dose-Ranging Study of SPC-15 an Intranasal Treatment for PTSD
- Positive aspects include the successful completion of the first phase of the dose-ranging study with no adverse clinical observations reported, the expected submission of a pre-IND application to the FDA during the first quarter of 2024, and the collaborative work with Columbia University for pre-clinical data on SPC-15.
- None.
Insights
The advancement of SPC-15, a prophylactic treatment for PTSD, into the later stages of pre-clinical trials is a significant stride for Silo Pharma. The ability to identify the maximum tolerated dose in small animals is a pivotal step before progressing to human trials. This data will be crucial for the Investigational New Drug (IND) application, a necessary precursor for FDA approval. The favorable preliminary results, with no adverse clinical observations, suggest a promising safety profile for SPC-15, which is paramount in the development of new drugs. The collaboration with Columbia University adds academic validation to the pre-clinical work, potentially strengthening the IND application.
Investors should note the importance of GLP (Good Laboratory Practice) compliance in later studies, as it is a regulatory requirement ensuring the quality and integrity of non-clinical laboratory studies. The transition from non-GLP to GLP studies will be a critical regulatory milestone. Furthermore, the focus on psychedelics for therapeutic purposes is a growing trend in the pharmaceutical industry and successful development could position Silo Pharma favorably within this niche market. However, as with any developmental stage biopharmaceutical company, there are substantial risks due to the possibility of future clinical failures, regulatory hurdles and the need for substantial capital.
The timeline for Silo Pharma's IND application submission is an essential factor for investors, as it will likely impact the company's stock performance. The market often reacts to the progression of pharmaceutical companies' drug pipelines, particularly when it comes to innovative treatments such as SPC-15. The lack of adverse clinical observations and the partnership with a reputable institution like Columbia University could be perceived positively by the market, potentially leading to an uptick in investor confidence.
However, it is crucial to understand that the biopharmaceutical sector is highly speculative and much of the company's valuation hinges on the successful advancement of its drug candidates. Investors should consider the inherent volatility and the long time frames associated with drug development. The financial health of Silo Pharma, including cash reserves and burn rate, will be important to monitor as the company moves towards more costly clinical trials and regulatory processes.
The market for PTSD treatments is substantial, with a significant unmet need for effective therapies. Silo Pharma's focus on merging traditional therapeutics with psychedelic research taps into a niche but expanding area of interest. The outcome of the SPC-15 development could have broader implications for the market, potentially influencing the strategies of other companies in the space. If Silo Pharma establishes a strong safety profile and advances to clinical trials, it could catalyze further investment and research into psychedelic-based treatments.
Understanding the competitive landscape is also critical. The entry of a new, effective PTSD treatment could disrupt current market dynamics and challenge existing therapies. It is important to analyze how Silo Pharma's approach differentiates from competitors and to assess the potential market size and adoption rates for SPC-15, should it receive FDA approval. The company's ability to secure partnerships or funding will be indicative of its commercial viability and potential market impact.
Final validation report expected in first quarter 2024
ENGLEWOOD CLIFFS, NJ, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today provided an update on its previously announced dose-ranging study of SPC-15, a targeted prophylactic treatment for post-traumatic stress disorder (PTSD). The purpose of the study is to identify the maximum tolerated intranasal dose of the drug and pharmacokinetic in small animals to determine the therapeutically relevant dose range with the goal of bringing us closer to human trials.
The six- to eight-week non-GLP study includes single ascending dose evaluation (phase 1) and a 7-day repeat intranasal dose toxicity and pharmacokinetic study. In the first phase of the study, all of the animals appeared to tolerate the intranasal dosing procedure well, with minimal struggling and no sneezing observed. The final validation report is expected in the first quarter of 2024.
Eric Weisblum, Chief Executive Officer of Silo Pharma, commented “There have been no adverse clinical observations reported to date for this study, which began in late November 2023 and will conclude in first quarter 2024. If successful, this non-GLP study will be followed by a GLP safety and toxicology study, both of which will be utilized in connection with filing an expected Investigational New Drug (IND) application with the FDA.”
Pre-clinical data has shown that SPC-15 has additive benefits for combating stress-induced pathophysiology, both at the behavioral and neural levels. Pre-clinical collaborative work with Columbia University will be coupled with published preclinical data in a pre-IND application to the FDA, which the Company expects to submit during the first quarter of 2024.
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. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the healthcare industry. For more information visit www.silopharma.com
Forward-Looking Statements
All statements other than statements of historical fact in this announcement are forward-looking statements that involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy, and financial needs. Investors can identify these forward-looking statements by words or phrases such as "may," "will," "expect," "anticipate," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company's filings with the SEC.
Contact
800-705-0120
investors@silopharma.com
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