A newly announced strategic partnership has catalyzed a significant surge in Silo Pharma, Inc. (NASDAQ: SILO) shares this morning. As of the most recent trading session, SILO stock has soared by 76.45%, reaching $3.97 per share.
Device and CMC Development Master Plan Initiation
Silo Pharma has revealed that it has entered into a Device and CMC Development Master Plan with Resyca BV, a prominent medical technology provider. Resyca BV is a collaborative venture between Bespak Group and Medspray Pharma BV, specializing in the production of a microchip-based spray system tailored for specific formulations. This innovative system has been selected by Silo Pharma for its leading candidate, SPC-15, an intranasal prophylactic treatment designed to address post-traumatic stress disorder (PTSD).
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SPC-15 is being developed as an intranasal medication, which, upon successful clinical trials, could potentially benefit from the FDA’s expedited regulatory approval process. Silo Pharma is actively conducting preclinical studies of SPC-15 in collaboration with Columbia University and has secured an exclusive license for its further development, manufacturing, and global commercialization.
Advanced Drug Delivery System
The patented nasal spray system employed for SPC-15 leverages state-of-the-art nose-to-brain drug dispersion technology. This delivery method facilitates the direct transport of drug molecules to the brain, circumventing the blood-brain barrier. Silo Pharma believes this approach could enhance the drug’s concentration in the brain, thereby providing a more rapid onset of therapeutic benefits and optimized safety for PTSD patients.
The Device and CMC Development Master Plan aims to support the clinical formulation, stability, and development of SPC-15 through an investigational new drug (IND)-enabling, large animal GLP (Good Laboratory Practice) study. Medspray Pharma BV and Silo Pharma have an exclusive licensing agreement that allows Silo Pharma to use Medspray’s spray mist technology for PTSD among other indications.
Presently, Silo Pharma is carrying out pharmacokinetic and pharmacodynamic studies that comply with GLP, and it has just sent a pre-IND briefing package and a request for a meeting to the FDA for SPC-15. The ultimate goal of these investigations is to start the first human clinical trial; these are the last stages before submitting an IND application to the FDA.
