Silo Pharma and Resyca BV Collaborate on Intranasal PTSD Drug Development

SARASOTA, FL, July 18, 2024 -- Silo Pharma, Inc. (Nasdaq: SILO), a developmental stage biopharmaceutical company dedicated to developing innovative drug formulations and delivery systems for both traditional and psychedelic treatments, has recently entered a Device and CMC Development Master Plan with Resyca BV. Resyca is a collaborative venture between Bespak Group and Medspray Pharma BV, which produces the specialized microchip-based spray system selected by Silo for its primary candidate, SPC-15. This candidate is an intranasal treatment aimed at preventing post-traumatic stress disorder (PTSD).

The Chief Executive Officer of Silo Pharma, Eric Weisblum, highlighted the advantages of the nasal spray system, which uses advanced nose-to-brain drug dispersion technology. This method allows the molecules to bypass the blood-brain barrier, directly reaching the brain. Weisblum suggested that for SPC-15, this could result in higher drug concentration in the brain, leading to a quicker onset of therapeutic effects and improved safety for patients with PTSD.

The Device and CMC Development Master Plan is designed to support the development, clinical formulation, and stability of a previously announced large animal GLP (Good Laboratory Practice) study for SPC-15. Under an existing exclusive license agreement with Medspray Pharma BV, a partner in the Resyca joint venture, Silo has exclusive rights to utilize Medspray's spray mist technology for various applications, including PTSD.

Currently, Silo Pharma is conducting GLP-compliant pharmacokinetic and pharmacodynamic studies and has recently submitted a pre-IND briefing package and meeting request to the U.S. Food and Drug Administration (FDA) for SPC-15. These studies represent the final steps needed before submitting an IND application to the FDA, with the objective of initiating the first human clinical trial.

SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist that leverages biomarkers to treat PTSD, anxiety, and other stress-related disorders. It is being developed as an intranasal medication. Should SPC-15 prove clinically successful, it may qualify for the FDA's expedited 505(b)(2) regulatory pathway for drug approval. Silo Pharma is conducting preclinical studies of SPC-15 in collaboration with Columbia University and has been granted exclusive rights to further develop, manufacture, and commercialize SPC-15 globally.

Silo Pharma Inc. is a developmental stage biopharmaceutical company focused on creating novel therapeutics for conditions that are currently underserved, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The company's primary program, SPC-15, targets PTSD and stress-induced anxiety disorders using an intranasal delivery system. Another key program, SP-26, involves a time-release ketamine-loaded implant for treating fibromyalgia and chronic pain. Silo's preclinical initiatives include SPC-14, an intranasal compound aimed at treating Alzheimer's disease, and SPU-16, a CNS-homing peptide intended for multiple sclerosis. Silo conducts its research and development in collaboration with Columbia University and the University of Maryland, Baltimore.

This latest agreement and the development of SPC-15 underscore Silo Pharma's commitment to pioneering advanced treatments for complex conditions by leveraging cutting-edge drug delivery systems and collaborations with leading research institutions.

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