Silo Pharma, a biopharmaceutical company listed on NASDAQ (SILO), has announced a partnership with Resyca BV, a medical technology provider, to develop an innovative intranasal delivery system for its lead treatment for post-traumatic stress disorder (PTSD), known as SPC-15. The collaboration aims to conduct a study that evaluates a microchip-based nasal spray designed to deliver the drug effectively by bypassing the blood-brain barrier.
The intranasal delivery system is engineered to allow the drug to reach the brain directly, which could lead to quicker therapeutic effects while maintaining a focus on safety. According to Silo Pharma’s CEO, Eric Weisblum, this method aims to increase the concentration of the drug in the brain, potentially providing faster relief for PTSD patients.
The upcoming study will supply crucial data needed for Silo Pharma’s Investigational New Drug (IND) application, which the company plans to submit to the FDA by 2025. This submission is part of a larger strategy to bring SPC-15 to market, focusing on treating stress-related psychiatric conditions.
In addition to the drug-device study with Resyca, Silo Pharma is also conducting two other studies related to SPC-15. One study is a Good Laboratory Practice (GLP) compliant toxicology and toxicokinetics study designed to support IND-enabling research. The second study, requested by the FDA, involves a 7-day safety and toxicology evaluation in large animals.
SPC-15 acts as a serotonin 5-HT4 receptor agonist targeting stress-induced psychiatric disorders, including PTSD and anxiety. The drug is positioned to take advantage of the FDA’s 505(b)(2) regulatory pathway, which may expedite its approval process.
Silo Pharma has secured exclusive global rights for the development and commercialization of SPC-15 and is collaborating with Columbia University for preclinical studies, further reinforcing its research foundation.
Resyca BV, established in 2020, specializes in developing and manufacturing compact, user-friendly nasal spray devices, employing proprietary micro-nozzle technology. This partnership with Silo Pharma allows both companies to leverage their expertise in drug delivery systems to advance treatment options for mental health conditions.
While this initiative shows promise, it is essential to note that SPC-15 is still in the early stages of development, and no FDA approval has been granted yet. Additional studies and regulatory approvals will be necessary before commercialization can occur. The ongoing research signifies a proactive approach to addressing the treatment needs of individuals suffering from PTSD and related disorders.
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