Silo Pharma initiates key trials for PTSD nasal therapy

Silo Pharma, Inc. (NASDAQ:SILO), based in Sarasota, Florida, is advancing its research on a new intranasal therapy aimed at treating post-traumatic stress disorder (PTSD). The biopharmaceutical company has entered an agreement with Frontage Laboratories to conduct a critical safety study for its treatment candidate, SPC-15.

This study follows an FDA directive calling for a 7-day safety and toxicology trial in large animals, a requirement essential for progressing towards an Investigational New Drug (IND) application. In the past week, Silo Pharma’s stock has risen over 35%, reflecting investor confidence as the company prepares to submit its IND application within the year.

CEO Eric Weisblum emphasized that the results of this safety study will bolster the data needed for the IND submission, which could pave the way for initiating clinical trials by 2025. Currently, Silo Pharma is conducting an additional Good Laboratory Practice (GLP) toxicology study for SPC-15.

SPC-15 operates as a serotonin 5-HT4 receptor agonist delivered through the nasal route, targeting psychiatric disorders influenced by stress, such as PTSD and anxiety. Utilizing the FDA’s 505(b)(2) regulatory pathway may allow for a faster approval process for this therapy.

Silo Pharma has secured an exclusive global license from Columbia University, which collaborates with the company on the preclinical development of SPC-15. Frontage Laboratories, the organization conducting the safety study, operates globally, with facilities in the U.S., Canada, Italy, and China, and specializes in drug discovery and development.

In addition to SPC-15, Silo Pharma is also working on treatments for fibromyalgia, chronic pain, Alzheimer’s disease, and multiple sclerosis, with ongoing research partnerships with leading academic institutions. Recently, the company reported positive preclinical results for its SP-26 extended-release ketamine implant for fibromyalgia, meeting all study endpoints without any adverse events related to the implant.

Furthermore, Silo Pharma filed a patent application for SPC-14, another treatment targeting Alzheimer’s disease, focusing on specific receptors linked to cognitive symptoms. In another positive development, the company received a patent for a pharmacological agent designed to prevent stress-induced affective disorders in females.

These advancements underline Silo Pharma’s dedicated efforts in mental health research and development. Investors and stakeholders are encouraged to stay informed about the next earnings report scheduled for May 28, 2025. As Silo Pharma continues its journey toward clinical trials, the outcomes of these studies could have a significant impact on the treatment landscape for PTSD and related conditions.