Silo Pharma Initiates Toxicity Study of its Proprietary Ketamine Formulation for Treatment of Fibromyalgia

Rhea-AI Summary

Silo Pharma has initiated a preclinical toxicity study of its new ketamine formulation, SP-26, targeting fibromyalgia treatment. This time-released ketamine has shown promising results in alleviating neuropathic nerve pain. The study aims to determine the tolerability of SP-26 in mini pigs, with results expected in Q1 2023. The company is also preparing an FDA Pre-Investigational New Drug application, pursuing a 505(b)(2) regulatory pathway for SP-26. The collaboration with Zylö Therapeutics focuses on utilizing Z-pod™ technology for effective ketamine delivery.

Positive

• Initiation of preclinical toxicity study for SP-26 targeting fibromyalgia.
• Positive results reported in reducing neuropathic nerve pain.
• Collaboration with Zylö Therapeutics enhances drug delivery technology.
• Preparation of FDA Pre-IND package indicates progress in drug development.

Negative

• None.

Studies of SP-26, the company’s proprietary, time-released ketamine show positive results in reducing neuropathic nerve pain 

ENGLEWOOD CLIFFS, NJ, Oct. 10, 2022 (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 initiated a preclinical toxicity study of its novel time-released, dosage controlled formulation of ketamine, designated as SP-26, for the treatment of fibromyalgia.

Eric Weisblum, CEO of Silo Pharma, commented, “We are working closely with our joint venture partner Zylö Therapeutics in developing a topical sustained released ketamine utilizing Z-pod™ technology. Preclinical studies have already shown that our joint developed delivery method and formulation can hold and distribute ketamine in a time-released manner.  SP-26 reported positive results in reducing neuropathic nerve pain. This safety evaluation study will uncover maximum tolerated dosing data that will inform our future trials.”

In the safety evaluation study, the tolerability of the SP-26 compound will be determined in a mini pig study using an ascending (descending) dosing regimen. Data from the study is expected in the first quarter of 2023.

Silo Pharma recently announced that it is working with a regulatory partner to prepare an FDA Pre-Investigational New Drug (IND) package for SP-26. The Company intends to pursue a 505(b)(2) regulatory pathway for the drug candidate.

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, 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 
800-705-0120
investors@silopharma.com

FAQ

What is SP-26 and its significance for Silo Pharma?

SP-26 is a proprietary, time-released ketamine formulation developed by Silo Pharma, aimed at treating fibromyalgia and has shown positive results in reducing neuropathic pain.

What are the expected outcomes of the SP-26 preclinical toxicity study?

The study will assess the tolerability of SP-26 in mini pigs, providing data for maximum tolerated dosing, expected in Q1 2023.

What regulatory pathway is Silo Pharma pursuing for SP-26?

Silo Pharma intends to pursue a 505(b)(2) regulatory pathway for SP-26, preparing an FDA Pre-IND package.

When will the results of the SP-26 study be available?

Results from the SP-26 preclinical toxicity study are expected in the first quarter of 2023.