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Planned SAD and MAD Studies Mark Key Clinical Inflection Point for Intranasal PTSD and Anxiety
SILO Pharma, Inc. (Nasdaq: SILO) ("SILO" or the "Company"), a diversified developmental stage biopharmaceutical and cryptocurrency treasury company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced it has entered into a non-binding Letter of Intent ("LOI") with Allucent (US) LLC ("Allucent"), a global clinical research organization (CRO), to provide clinical research services for two planned Phase 1 studies evaluating its SPC-15 nasal spray in healthy subjects: an Open-Label, Single Ascending Dose (SAD) study and an Open-Label, Multiple Ascending Dose (MAD) study.
Allucent and Silo intend to negotiate a Master Services Agreement and project-specific Work Order to cover a comprehensive scope of activities across clinical operations, pharmacovigilance, data management, biostatistics, clinical pharmacology modeling & simulation, and medical writing to support execution and reporting of the Phase 1 program. The LOI also outlines proposed payment conditions, including an upfront amount for direct service fees and pass-through costs that would be reconciled against final project invoices.
"This letter of intent with Allucent could lead to a meaningful step forward in advancing SPC-15 into Phase 1 clinical development," said Eric Weisblum, Chief Executive Officer of Silo Pharma. "Their global CRO expertise and integrated clinical capabilities appear to align well with our goal of efficiently generating high-quality safety and pharmacokinetic data. We believe this collaboration will allow us to execute our SAD and MAD studies with rigor and speed. Advancing SPC-15 remains a key priority as we strive to build long-term value across our pipeline."
About SPC-15
SPC-15 is an investigational intranasal serotonin 5-HT4 receptor agonist being developed by Silo Pharma for stress-induced psychiatric conditions, primarily Post-Traumatic Stress Disorder (PTSD) and anxiety, using a special soft mist nasal spray delivery system for fast brain action. It's in preclinical stages, partnering with Columbia University, and aims for an accelerated FDA approval pathway (505(b)(2)) by leveraging biomarkers and novel delivery
About Silo Pharma
Silo Pharma is a diversified developmental-stage biopharmaceutical and cryptocurrency treasury company. Its therapeutic focus is 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 the Company to differ materially from the results expressed or implied by such statements, including statements pertaining to the intended use of proceeds from the offering, 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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