Silo Pharma Announces Completion of FDA Pre-IND Meeting to Advance Development of SPC-15 for Treatment of PTSD
September 10 2024 - 6:35AM
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 the
completion of a pre-Investigational New Drug (pre-IND) meeting with
the U.S. Food and Drug Administration (FDA) regarding the Company's
development plan for SPC-15, an intranasal prophylactic treatment
for post-traumatic stress disorder (PTSD) and stress-induced
anxiety disorder. The pre-IND meeting was completed through written
responses provided by the FDA’s Division of Regulatory Operations
for Neuroscience (DRON) - Psychiatry Group.
The primary purpose of the pre-IND meeting was
to align with the FDA on the 505(b)(2) regulatory pathway for
approval of SPC-15 along with Silo’s proposed plan to support
opening an IND. The FDA’s 505(b)(2) drug development route can
significantly shorten clinical timelines for FDA approval and
reduce drug development costs.
“The FDA provided helpful written responses on
our development plan for SPC-15," said Silo CEO Eric Weisblum. “We
now have a clear path for advancing our development of SPC-15 into
the clinic for in-human trials which will hopefully lead to FDA
approval and ultimately allow us to commercialize our patented,
cutting-edge intranasal treatment, to the PTSD treatment
market.”
Silo is currently conducting a GLP-compliant
pharmacokinetic and pharmacodynamic study in advance of an IND
submission for a potential first-in-human (FIH) clinical trial of
SPC-15. Pre-clinical data to date indicate that SPC-15’s optimized
patient safety and therapeutic delivery has additive benefits for
combating stress-induced pathophysiology, both at the behavioral
and neural levels. Columbia University has granted Silo an
exclusive license to further develop, manufacture, and
commercialize SPC-15 worldwide.
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 and was granted an exclusive license to further
develop, manufacture, and commercialize SPC-15 worldwide.
About 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
universities and independent laboratories. 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
800-705-0120investors@silopharma.com
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