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SILO Positive Sentiment Score: 85/100

Silo Pharma Announces Positive Results from IND-Enabling Study of SP-26 for Fibromyalgia

Key Takeaway: Silo Pharma announced positive results from its toxicology study of SP-26, a novel formulation of ketamine, indicating feasibility for future human trials. The study, conducted in collaboration with Experimur, aligns with FDA requirements for advancing to clinical studies. CEO Eric Weisblum emphasized the importance of these results in preparing a Pre-IND package to pursue the FDA's expedited regulatory pathway. The company aims to merge traditional therapeutics with psychedelic research for conditions like fibromyalgia.

Market Sentiment Analysis

POSITIVE FACTORS

  • Silo Pharma achieved positive results for the SP-26 toxicology study.
  • The study assessed the feasibility for human trials of SP-26.
  • The company plans to submit a Pre-IND package to the FDA.
  • The streamlined 505(b)(2) pathway may expedite drug approval.

Full Press Release Details

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.”
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.

Frequently Asked Questions

What are the positive results from Silo Pharma's toxicology study?

Silo Pharma reported favorable results from its toxicology study of SP-26, validating the feasibility of its dosing design.

What is SP-26 developed for?

SP-26 is a novel formulation of ketamine aimed at treating PTSD, Alzheimer’s, and rare neurological disorders.

Who conducted the toxicology study for SP-26?

The toxicology study for SP-26 was conducted in collaboration with Experimur, part of Frontage Laboratories.

What regulatory pathway will Silo Pharma pursue for SP-26?

Silo Pharma intends to pursue the FDA's streamlined 505(b)(2) regulatory pathway for SP-26.

What is Silo Pharma's mission?

Silo Pharma aims to merge traditional therapeutics with psychedelic research to enhance patient well-being.

Last updated: Mar 15, 2023