Full Press Release Details
Nose-to-Brain Drug Delivery Shows Promising Patient Safety and Therapeutic Benefit
The Device and CMC Development Master Plan is designed to support IND-enabling studies
SARASOTA, FL, July 18, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced it has entered into a Device and CMC Development Master Plan with Resyca BV, a medical technology provider. Resyca is a joint venture between Bespak Group and Medspray Pharma BV which manufactures the formulation-specific microchip-based spray system chosen by Silo for its lead candidate SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
“The patented nasal spray system uses cutting-edge nose-to-brain drug dispersion, a delivery method that transports the molecules to the brain directly, bypassing the blood-brain barrier,” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “For SPC-15, we believe this delivery method could increase the drug’s concentration in the brain to deliver a faster onset of therapeutic benefit and optimized safety for PTSD patients.”
This Device and CMC Development Master Plan is intended to support the development, clinical formulation, and stability of a previously announced investigational new drug (IND)-enabling, large animal GLP (Good Laboratory Practice) study of SPC-15. As part of an existing exclusive license agreement with Medspray Pharma BV, one of joint venture members of Resyca BV, Silo holds exclusive rights to Medspray’s spray mist technology for use with multiple indications including PTSD.
Silo is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic studies and recently submitted a pre-IND briefing package and meeting request to the U.S. Food and Drug Administration (FDA) for SPC-15. The studies are the final steps required before submission of an IND application to the FDA with the goal of starting its first in human clinical trial.
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist that utilizes biomarkers for the treatment of PTSD, anxiety, and other stress-induced affective disorders. SPC-15 is being developed as an intranasal medication. If clinically successful, SPC-15 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Silo Pharma is conducting preclinical studies of SPC-15 in collaboration with Columbia University and was granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The Company’s lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo’s research and development programs are conducted through collaborations with Columbia University and the University of Maryland, Baltimore. For more information, visit www.silopharma.com and connect on social media at LinkedIn, X, and Facebook.
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.