Final validation report expected in first quarter 2024
ENGLEWOOD CLIFFS, NJ, Jan. 04, 2024 — 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.
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