Silo Pharma Announces Strategic Focus on Psychedelic and Traditional Therapeutics for 2024

LOS ANGELES- Silo Pharma, Inc., a developmental stage biopharmaceutical company, has outlined a strategic focus for its clinical pipeline in 2024, emphasizing the advancement of novel formulations and drug delivery systems for both traditional therapeutics and psychedelic treatments. The company is set to prioritize the development of four innovative drugs targeting critical health areas: mental health, chronic pain, and neurology.

Eric Weisblum, CEO of Silo, announced the company’s intent to submit a Pre-Investigational New Drug Application (IND) for its post-traumatic stress disorder (PTSD) therapeutic, SPC-15, to the U.S. Food and Drug Administration (FDA) by the end of the second fiscal quarter in 2024. This move is in collaboration with Columbia University, highlighting the company’s commitment to addressing the significant needs within the mental health sector.

SPC-15, Silo’s lead program, is designed as an intranasal prophylactic treatment for PTSD and stress-induced anxiety disorder, areas currently underserved by the pharmaceutical industry. With a dose-ranging non-GLP study of SPC-15 in progress, and a final validation report expected in the first half of 2024, the drug represents a potential breakthrough for the 3.5% of U.S. adults affected by PTSD.

In addition to SPC-15, Silo is developing SP-26, a non-opioid chronic pain solution for fibromyalgia. This innovative treatment, a ketamine-loaded implant administered through subcutaneous injection, could become the first at-home ketamine treatment approved for chronic pain management, marking a significant advance in the field.

The company’s collaboration with Columbia University has also yielded SPC-14, a promising therapeutic for Alzheimer’s disease. With positive initial results from animal studies and more data expected in 2024, SPC-14 offers hope in the ongoing battle against this devastating neurodegenerative condition.

Silo’s commitment to neurology extends to SPU-16, developed in collaboration with the University of Maryland, Baltimore (UMB), targeting multiple sclerosis (MS). This novel peptide aims to cross the blood-brain barrier and target damaged tissue and inflammation, offering new possibilities for MS treatment.

Silo plans to leverage the FDA’s streamlined 505(b)(2) pathway for the approval of its drug candidates, including SPC-15, SP-26, and SPC-14. This regulatory strategy, which allows the inclusion of external data in IND submissions, could significantly expedite the approval process and reduce development costs.

Through strategic collaborations and a focused approach to drug development, Silo Pharma aims to bring innovative solutions to the forefront of medical care, addressing underserved diseases and offering new hope to patients with limited treatment options.