Silo Pharma (Nasdaq: SILO) partnered with Resyca BV to conduct a drug-device study for their lead asset, SPC-15, an intranasal PTSD treatment. This study will gather crucial data on the microchip-based nasal spray system used to deliver SPC-15, paving the way for an Investigational New Drug (IND) application to the FDA later this year. In addition to this device study, Silo Pharma is also conducting IND-enabling toxicology and toxicokinetics studies, along with a 7-day safety and toxicology study in large animals, as requested by the FDA.
This development marks significant progress toward potential clinical trials for SPC-15. Demonstrating the efficacy of the nasal spray delivery system is critical for Silo Pharma’s strategy. This direct brain delivery method, bypassing the blood-brain barrier, is a key differentiator for SPC-15 and could potentially lead to faster onset of action and improved safety profiles, which are highly desirable for PTSD treatments. Positive results from the device study would not only support the IND submission but also build investor confidence in the technology’s potential. This progress strengthens Silo Pharma’s position in the developing landscape of PTSD therapeutics.
The collaboration with Resyca BV, a specialist in micro-nozzle technology for nasal spray devices, highlights Silo Pharma’s commitment to advanced drug delivery systems. SPC-15, a serotonin 5-HT4 receptor agonist, is being developed under the FDA’s 505(b)(2) regulatory pathway, a potentially faster route to market. Silo Pharma holds global rights to SPC-15’s development and commercialization and is collaborating with Columbia University on preclinical studies.
Successful completion of the drug-device study and subsequent IND submission would be a pivotal milestone for Silo Pharma. This would initiate the clinical phase of development for SPC-15, potentially offering a novel treatment option for individuals suffering from PTSD. This forward momentum could attract further investment and partnerships, solidifying Silo Pharma’s position in the biopharmaceutical industry.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
