Silo Pharma Partners with Resyca for IND-Supporting Intranasal Drug-Device Study of PTSD Drug SPC-15
Rhea-AI Summary
Silo Pharma (NASDAQ: SILO) has partnered with medical technology provider Resyca BV for a drug-device study of SPC-15, its lead asset for post-traumatic stress disorder (PTSD) treatment. The study will focus on the formulation-specific microchip-based nasal spray system used to deliver the drug.
The intranasal delivery system is designed to bypass the blood-brain barrier, potentially enabling faster therapeutic benefits with optimized safety. This study is expected to provide the final device data and documentation needed for the company's planned FDA IND submission in 2025.
Additionally, Silo is conducting two other SPC-15 studies: an IND-enabling GLP-compliant toxicology and toxicokinetics study, and an FDA-requested 7-day safety and toxicology large animal study.
Positive
- Partnership with Resyca BV advances development of innovative drug delivery system
- Direct-to-brain delivery system potentially offers faster therapeutic benefits
- Company progressing towards FDA IND submission in 2025
- Multiple concurrent studies demonstrate advancement in drug development pipeline
Negative
- Still in early developmental stage with no FDA approval yet
- Additional studies and regulatory approvals required before commercialization
Study is expected to deliver final device data and documentation needed for planned FDA IND submission
SARASOTA, FL, May 21, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has entered into a service agreement with medical technology provider Resyca BV for a drug-device study of the formulation-specific microchip-based nasal spray system used in its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
“This study is expected to provide the final necessary device data and documentation for SPC-15’s IND, which we plan to submit to the FDA this year,” said Eric Weisblum, CEO of Silo. “Our chosen device transports the molecules to the brain directly, bypassing the blood-brain barrier, to increase drug concentration. We believe this method can drive faster onset of therapeutic benefit with optimized safety for the treatment of PTSD patients.”
The Company is currently conducting two additional SPC-15 studies: an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study, and an FDA requested 7-day safety and toxicology large animal study.
About SPC-15
SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders such as PTSD and anxiety. With its potential eligibility for the FDA’s streamlined 505(b)(2) regulatory pathway, SPC-15 offers a promising approach to accelerate the approval process. Silo Pharma is collaborating with Columbia University to conduct preclinical studies and has exclusive global rights to the development and commercialization of SPC-15.
About Resyca
Resyca BV was founded in 2020 and is a joint venture between Bespak Limited and Medspray Pharma BV. Resyca BV specializes in the development and manufacturing of compact, user-friendly soft mist inhalation and soft nasal spray devices, incorporating the proprietary Medspray micro-nozzle technology. These devices are tailored for pulmonary and nasal applications, utilising standard pre-filled syringes / primary packaging and filling lines. As the soft mist development centre within Bespak, Resyca offers comprehensive services spanning from early-stage development through to commercial production, inclusive of filling, labelling, and packaging.
About Silo Pharma
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company’s portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease and multiple sclerosis. Silo’s research is conducted in collaboration with leading universities and laboratories. silopharma.com
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 using 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 the Company’s ability to successfully complete its preclinical studies and generate positive data, the risk that the FDA may not accept or may require changes to the IND, or may not allow the Company to proceed with clinical trials, the risk that the FDA may not approve SPC-15 on the Company’s expected timeline, or at all, 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 press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law.
Contact
800-705-0120
investors@silopharma.com
FAQ
What is the purpose of Silo Pharma's partnership with Resyca BV for SPC-15?
How does SILO's SPC-15 drug delivery system work for PTSD treatment?
What studies is Silo Pharma (SILO) currently conducting for SPC-15?
When does Silo Pharma plan to submit the IND application for SPC-15 to the FDA?
