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Positive data supports the continued advancement of FDA Investigational New Drug (IND)- enabling development program
SILO Pharma (Nasdaq: SILO) ("SILO" or "the Company"), a developmental-stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has confirmed the physical, chemical and microbiological stability of its investigational soft-mist intranasal prophylactic, SPC-15, through nine months of real-time testing. The stability data demonstrates that SPC-15's formulation maintains physical, chemical, and microbiological integrity over nine months at long term and six months at accelerated conditions.
The stability program was conducted under long-term and accelerated storage conditions aligned
with requirements for investigational new drug (IND)-enabling chemistry, manufacturing, and controls (CMC) documentation. Data showed that SPC-15's formulation and device remained within predefined specifications for assay, impurities, pH, and microbiological quality through nine months, and the product remained in trend for predefined key device spray performance tests. Six-month accelerated stability data was consistent and aligned with long term data.
"The positive stability data support continued advancement of our IND-enabling development program and contribute to the manufacturing information required in an IND submission for a first-in-human Phase 1 clinical study," said Eric Weisblum, CEO of Silo Pharma. "This important milestone validates our adherence to current Good Manufacturing Practice (cGMP) standards."
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, Inc.
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. 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 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.
Contact
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