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 Study designed to evaluate performance and formulation stability of proprietary nose-to-brain delivery system
SILO Pharma (Nasdaq: SILO) ("SILO" or "the Company"), a diversified developmental-stage biopharmaceutical company with a therapeutic focus on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases, today announced that it has engaged its drug-device development partner Resyca to conduct a robustness study evaluating the microchip-based nasal spray system used for nose-to-brain delivery of SPC-15, the Company's lead intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
"We believe this robustness study represents another important step toward initiating our first-in-human clinical program for SPC-15," said Eric Weisblum, Chief Executive Officer of Silo Pharma. "Together with our previously completed preclinical studies, these data are expected to support our planned FDA Type C meeting request, where we intend to obtain regulatory guidance on our IND strategy and Phase 1 clinical trial design."
Resyca's patented Soft-Mist Nasal Spray system is designed for targeted nose-to-brain drug delivery, enabling molecules to bypass the blood-brain barrier. Silo believes this approach has the potential to increase drug concentrations in the brain while reducing systemic exposure, potentially enabling faster therapeutic onset and an improved safety profile. Drug-device robustness testing is a standard component of combination-product development and is intended to demonstrate consistent device performance and formulation stability prior to clinical evaluation. Silo's robustness study will evaluate device performance consistency during expected use and assess formulation stability of SPC-15 formulations (lead and placebo) over a 30-day period.
The U.S. Food and Drug Administration's (FDA) IND Type C meeting is a formal interaction with the FDA to obtain regulatory feedback on drug development programs outside of standard milestone meetings. In a previous pre-IND meeting with the FDA, Silo successfully aligned with the FDA on the streamlined 505(b)(2) regulatory pathway for approval of SPC-15.Â
About Silo Pharma, Inc.
Silo Pharma is a diversified developmental-stage biopharmaceutical company with a therapeutic focus 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 post-traumatic stress disorder (PTSD), SP-26 for fibromyalgia and chronic pain, and a preclinical asset targeting Alzheimer's disease. 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 the Company to differ materially from the results expressed or implied by such statements, including statements about 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.
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