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Silo Pharma Initiates Human Factor Study of SPC-15 for the Treatment of PTSD

Key Takeaway: Silo Pharma, Inc. has announced the initiation of a human factor study for its intranasal treatment SPC-15, aimed at addressing post-traumatic stress disorder (PTSD). This study will evaluate the usability of SPC-15's delivery mechanism and is expected to be completed by the end of 2023. If successful, SPC-15 could benefit from the FDA's 505(b)(2) regulatory pathway for approval. The company collaborates with Columbia University for preclinical studies while aiming to provide innovative solutions for PTSD and related disorders.
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POSITIVE FACTORS

  • Silo Pharma initiates important human factor study for SPC-15.
  • SPC-15 shows promise as a treatment for PTSD and other disorders.
  • Potential qualification for the FDA's streamlined approval pathway.

CONCERNS & RISKS

  • The company cautions that actual results may differ from expectations.
  • The project is at a developmental stage and outcomes are uncertain.

Full Press Release Details

Study to test effectiveness of Instructional System Designs (ISD) model for Intranasal SPC-15
ENGLEWOOD CLIFFS, NJ, Oct. 11, 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 human factor study of its targeted prophylactic treatment SPC-15 for the treatment of post-traumatic stress disorder (PTSD). The study will evaluate the human factor interface and usability of SPC-15’s intranasal formulation in combination with a nose-to-brain delivery mechanism.
“The human factors study is an important step as we prepare and plan to enter the clinic with SPC-15 for the treatment of PTSD and stress-related disorders,” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “The first of the two-part study was launched in October, with the expected completion of this study before year end 2023.
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 pursuant to a sponsored research agreement and option.
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.

Frequently Asked Questions

What is the purpose of the human factor study for SPC-15?

The study aims to assess the usability and interface of SPC-15's intranasal formulation.

What conditions does SPC-15 aim to treat?

SPC-15 targets PTSD, anxiety, and other stress-induced affective disorders.

What regulatory pathway might SPC-15 qualify for?

SPC-15 could qualify for the FDA’s streamlined 505(b)(2) approval pathway.

Who is partnering with Silo Pharma for the SPC-15 studies?

Silo Pharma is collaborating with Columbia University for preclinical studies.

When is the human factor study expected to be completed?

The study is expected to be completed before the end of 2023.

Last updated: Oct 11, 2023