Silo Pharma Inc. has announced a new clinical study in collaboration with Resyca BV, focusing on the drug-device combination for their lead asset, SPC-15. The study aims to collect the final device data and documentation necessary for an Investigational New Drug $(IND.AU)$ submission to the U.S. Food and Drug Administration (FDA) later this year. SPC-15 is designed as an intranasal treatment for post-traumatic stress disorder (PTSD) and utilizes a microchip-based nasal spray system to deliver molecules directly to the brain, bypassing the blood-brain barrier. This approach is intended to increase drug concentration and potentially enhance therapeutic outcomes. Currently, Silo Pharma is also conducting an IND-enabling GLP-compliant toxicology and toxicokinetics study, along with an FDA-requested 7-day safety and toxicology study in large animals.
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