Silo Pharma’s PTSD Drug SPC-15 Advances to Human Trials

Silo Pharma, a biopharmaceutical company focused on developing treatments for mental health disorders, has taken a significant step forward in its quest to bring an intranasal treatment for post-traumatic stress disorder (PTSD) to market. The company has initiated a 7-day safety and toxicology study for its lead drug candidate, SPC-15, at Frontage Laboratories. This study is a critical component of the preparations for an upcoming investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA).

The goal of the safety study is to gather additional data that will support the IND application. In parallel, Silo Pharma is conducting another toxicology study that complies with Good Laboratory Practice (GLP) standards, which is also required for the IND submission. The company plans to submit the IND application in 2025. Once the FDA grants approval, Silo will initiate the first-in-human Phase 1 clinical trial for SPC-15.

SPC-15 is designed as an intranasal treatment that targets serotonin 5-HT4 receptors, which play a role in managing stress-induced psychiatric disorders, including PTSD and anxiety. This innovative approach could streamline the treatment process for individuals suffering from these conditions. The development of SPC-15 benefits from an exclusive global license granted by Columbia University, providing Silo with rights to develop, manufacture, and commercialize the drug worldwide.

Silo Pharma’s move into human trials represents a promising advancement in the field of PTSD treatment, which is a significant area of need. The rise in PTSD diagnoses, particularly among veterans and survivors of trauma, highlights the urgency for effective therapies. The market for PTSD treatment is substantial, with billions of dollars in potential revenue available for effective solutions.

As the clinical trial phase approaches, Silo Pharma emphasizes the importance of the ongoing studies. Eric Weisblum, CEO of Silo, stated, “We are conducting a 7-day safety and toxicology study to gather additional data that is expected to supplement and reinforce our SPC-15 investigational new drug (IND) application to the FDA.”

The company’s pathway to clinical trials is supported by positive preclinical data from earlier studies, which, if replicated, will bolster their case for FDA approval. This drug candidate has the potential to provide a new option for patients who have limited treatment choices available to them.

As Silo Pharma progresses toward human trials, the mental health community will be closely monitoring the outcomes of these studies. The successful development of SPC-15 could lead to improved treatment options for those grappling with the debilitating effects of PTSD.