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SARASOTA, FL - Silo Pharma, Inc. (NASDAQ:SILO), a biopharmaceutical company specializing in novel therapeutics and drug delivery systems with a market capitalization of $4.93 million, has announced an agreement with Frontage Laboratories for a key safety study on its PTSD treatment candidate, SPC-15. The company’s stock has shown strong momentum, gaining over 35% in the past week, according to InvestingPro data. The study is a response to an FDA request for a 7-day safety and toxicology large animal study, which is a critical step towards an Investigational New Drug (IND) application for the intranasal treatment.
The CEO of Silo, Eric Weisblum, stated that this study is expected to supplement the data for the company’s forthcoming IND submission, with plans to initiate the FDA submission process within the year. InvestingPro analysis shows the company maintains a healthy financial position with a current ratio of 4.73, indicating strong ability to meet short-term obligations, and impressive gross profit margins of 91.9%. Currently, Silo is conducting a separate IND-enabling Good Laboratory Practice (GLP) toxicology and toxicokinetic study of SPC-15. Positive outcomes from these studies could support an IND submission for SPC-15 in 2025, leading to a Phase 1 clinical trial.
SPC-15, a serotonin 5-HT4 receptor agonist administered intranasally, is designed to treat stress-induced psychiatric disorders like PTSD and anxiety. The drug could benefit from the FDA’s 505(b)(2) regulatory pathway, which may expedite the approval process. Silo has secured an exclusive global license from Columbia University, its collaboration partner for preclinical development, to develop, manufacture, and commercialize SPC-15.
Frontage Laboratories, the contracted CRO for this study, is a global pharmaceutical development and manufacturing organization with facilities across the United States, Canada, Italy, and China. They provide a wide range of services for drug discovery and development.
Silo Pharma’s portfolio also includes treatments for fibromyalgia, chronic pain, Alzheimer’s disease, and multiple sclerosis, with research conducted in partnership with leading universities and laboratories.
The information in this article is based on a press release statement from Silo Pharma. It should be noted that forward-looking statements involve risks and uncertainties, and actual results may differ materially from those projected in such statements. Silo Pharma has not made any assurances that the FDA will accept their IND application or allow them to proceed with clinical trials. Investors should note that the company’s next earnings report is scheduled for May 28, 2025. For comprehensive financial analysis and additional insights, including 6 more exclusive ProTips, visit InvestingPro.
In other recent news, Silo Pharma, Inc. announced positive preclinical results for its extended-release ketamine implant, SP-26, aimed at treating fibromyalgia. The study met all endpoints, including survival and safety measures, and no implant-related adverse events were reported, suggesting potential for clinical trials. Additionally, Silo Pharma has filed a patent application for SPC-14, a drug targeting Alzheimer’s disease, with a unique approach involving specific receptors associated with cognitive symptoms. The development of SPC-14 is part of a research agreement with Columbia University, where Silo Pharma holds an exclusive global license. Furthermore, the company has initiated a crucial study for its PTSD treatment candidate, SPC-15, which is part of the regulatory process needed to advance toward first-in-human clinical trials. Silo Pharma’s strategy aligns with the FDA’s 505(b)(2) regulatory pathway, potentially expediting approval processes. In another development, Silo Pharma secured a patent for a pharmacological agent aimed at preventing stress-induced affective disorders in females, issued by the United States Patent and Trademark Office. This series of developments highlights Silo Pharma’s ongoing efforts in research and development within the pharmaceutical sector.
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