Silo Pharma Completes FDA Pre-IND Meeting for SPC-15 PTSD Treatment Development

Silo Pharma, Inc., a developmental stage biopharmaceutical company, has made significant strides in its advancement of SPC-15, a novel intranasal treatment aimed at addressing post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder. The company recently completed a crucial pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA). This meeting, facilitated through written responses from the FDA’s Division of Regulatory Operations for Neuroscience (DRON) - Psychiatry Group, focused on aligning Silo Pharma’s development plan for SPC-15 with the FDA’s 505(b)(2) regulatory pathway. This pathway can potentially shorten clinical timelines for FDA approval and reduce development costs.

Eric Weisblum, CEO of Silo Pharma, expressed optimism following the FDA’s feedback. "The FDA provided helpful written responses on our development plan for SPC-15," Weisblum remarked. He highlighted that the company now has a clearer path to advance SPC-15 into in-human trials, which could eventually lead to FDA approval and commercialization. This approval could allow Silo Pharma to introduce its innovative intranasal treatment to the PTSD treatment market.

Currently, Silo Pharma is conducting GLP-compliant pharmacokinetic and pharmacodynamic studies as a precursor to submitting an IND for a potential first-in-human clinical trial of SPC-15. Initial preclinical data show promising results, indicating that SPC-15 offers optimized patient safety and effective therapeutic delivery. These benefits are particularly significant for addressing stress-induced behavioral and neural pathophysiology. Columbia University has granted Silo Pharma an exclusive license to further develop, manufacture, and commercialize SPC-15 on a global scale.

SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist that leverages biomarkers to treat PTSD, anxiety, and other stress-induced affective disorders. Developed as an intranasal medication, SPC-15 has the potential to qualify for the FDA’s expedited 505(b)(2) regulatory pathway if it proves clinically successful. Silo Pharma is collaborating with Columbia University on the preclinical studies of SPC-15 and has exclusive worldwide rights to its development, manufacturing, and commercialization.

Silo Pharma Inc., listed on Nasdaq under the ticker SILO, is focused on developing innovative therapeutics targeting underserved conditions such as stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. The company’s portfolio includes both traditional therapies and psychedelic treatments formulated in novel delivery systems. The lead program, SPC-15, is designed as an intranasal treatment for PTSD and stress-induced anxiety disorders. Another notable program is SP-26, a time-release ketamine-loaded implant aimed at treating fibromyalgia and chronic pain. Silo’s pipeline also features two preclinical programs: SPC-14, an intranasal compound for treating Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS).

Silo Pharma’s research and development efforts are carried out in collaboration with universities and independent laboratories. This approach has enabled the company to push the boundaries of traditional and psychedelic therapeutics through innovative formulations and drug delivery systems.