Silo Pharma to Initiate Dose-Ranging Study of Novel Intranasal Therapeutic SPC-15 for the Treatment of PTSD
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Study to determine therapeutic relevant dose range and pharmacokinetic to be used for first-in-human trial
ENGLEWOOD CLIFFS, NJ, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced plans to initiate a dose-ranging study of its targeted prophylactic treatment SPC-15 for the treatment of post-traumatic stress disorder (PTSD). The study will identify the maximum tolerated intranasal dose of the drug and pharmacokinetic in small animals to determine the therapeutically relevant dose range.
In collaboration with AmplifyBio, Silo Pharma’s contract research organization (CRO) partner, the six- to eight-week non-good laboratory practice (GLP) study will include single ascending dose evaluation (phase 1) and a 7-day repeat intranasal dose toxicity and pharmacokinetic study. The final validation report is expected in 2024.
“Determining the dose range that should be studied is an important step before taking a new drug candidate into a first-in-human trial,” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “Completion of this study, along with our recently announced human factor study, is expected to give us an early start on our goal of a Phase 1 clinical trial of 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.
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
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investors@silopharma.com
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