Silo Pharma Completes Successful Dose-Ranging Study of SPC-15 Intranasal Therapeutic for PTSD
28 Fevereiro 2024 - 10:25AM
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 positive
results from its non-GLP small animal dose-ranging study of SPC-15,
an intranasal prophylactic treatment for anxiety and post-traumatic
stress disorder (PTSD).
The purpose of the non-GLP small animal study was to identify
the maximum tolerated intranasal dose of the drug pharmacokinetic
and determine the therapeutically relevant dose range to be studied
in clinical trials. Data analysis demonstrated rapid absorption of
SPC-15 with good exposure over a 24-hour period, suggesting a
once-per-day human intranasal dosing regimen would be optimal.
“Non-GLP and GLP toxicology and safety pharmacology studies are
required steps before seeking approval for our first-in-human
clinical-stage trials of SPC-15,” said Eric Weisblum, CEO of Silo.
“We are currently on track to submit a pre-investigational New Drug
Application (IND) to the FDA by the end of the second quarter 2024.
This is an exciting step forward for our Company as we advance our
lead therapeutic, SPC-15.”
About SPC-15
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 under a sponsored
research agreement and option.
Silo Pharma
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.
Contact 800-705-0120 investors@silopharma.com
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