Silo Pharma Announces Positive Results from IND-Enabling Study of SP-26 for Fibromyalgia
Silo Pharma, Inc. (Nasdaq: SILO) announced positive results from its toxicology study of SP-26, a novel time-released ketamine formulation. Conducted in collaboration with Experimur, the study employed a maximum feasibility dosing regimen in mini pigs, conforming to FDA standards. CEO Eric Weisblum emphasized that these outcomes are crucial for advancing toward human trials. The company plans to submit a Pre-Investigational New Drug (IND) package and pursue the FDA's 505(b)(2) regulatory pathway for drug approval. This marks a significant step for Silo in its mission to combine traditional therapeutics with psychedelic research for neurological disorders.
- Achieved positive results in SP-26 toxicology study, advancing potential for human trials.
- Collaboration with Experimur enhances credibility and compliance with FDA standards.
- Plans to prepare Pre-IND package indicates progress towards drug approval.
- None.
ENGLEWOOD CLIFFS, NJ, March 15, 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 that it has achieved positive results for its toxicology study of SP-26, its novel time-released, dosage-controlled formulation of ketamine. The study results evaluated the feasibility of using a rising dose design or maximum feasibility.
In collaboration with Experimur, a Frontage Laboratories company, Silo Pharma tested SP-26 in a toxicology and tolerability study in mini pigs using an ascending (descending) dosing regimen. The study utilized the bioanalytical methods required to perform toxicology studies by the U.S. Food and Drug Administration (FDA) in advance of initiating clinical studies for SP-26.
“Today’s positive results are an important step as we move closer to achieving all needed components to plan human trials of SP-26.” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “We are advancing our work with our regulatory partners to prepare a Pre-Investigational New Drug (IND) package for SP-26 and intend to pursue the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.”
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 under takes 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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