Silo Pharma Announces Positive Data on SPC-15 for PTSD and Prepares to File Pre-Investigational New Drug (IND) Application with FDA
20 9월 2023 - 9:28PM
Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a
developmental stage biopharmaceutical company focused on merging
traditional therapeutics with psychedelic research, today announced
that based on positive SPC-15 pre-clinical data, it is working with
Kymanox as its regulatory partner to assist with the preparation of
a pre-Investigational New Drug (IND) package and meeting request
with the United States Food and Drug Administration (FDA). SPC-15
is a targeted intranasal prophylactic intended for the treatment
and prevention of anxiety, PTSD, and other stress-related
disorders.
“Our pre-clinical data indicate that SPC-15 has additive
benefits for combating stress-induced pathophysiology, both at the
behavioral and neural levels. In conjunction with Columbia
University, we are pleased to announce this milestone in advancing
our potential therapeutic development for those suffering from
stress-induced anxiety and PTSD. We are confident that our own
pre-clinical work coupled with published preclinical data provides
a strong foundation for our pre-IND application, which we plan to
submit during the first quarter of 2024,” stated Eric
Weisblum.”
Kymanox, a full-service life sciences solutions
provider, will provide regulatory affairs support to the Company
including the development of a clinical pharmacology and
biopharmaceutics strategy and program to be proposed to the FDA. A
pre-IND meeting request for collaborative discussions with the FDA
will be filed early 2024
SPC-15 utilizes metabolic biomarker profiling to treat anxiety,
PTSD, and other stress-related disorders. Its core technology,
which is patent-protected, predicts levels of severity and
progression of such disorders and informs their response to
pharmacological treatments and prevention.
About Kymanox:
Kymanox is a life science professional services organization
that offers engineering, scientific, project management, quality,
human factors, testing / QC, CQV, and regulatory support to
companies exclusively in the biotechnology, pharmaceutical, medical
device, and combination product industries. With its diverse
team of experts, Kymanox helps clients navigate commercialization
challenges that arise throughout a product’s life cycle – from
early development to post-market – with optimized safety, quality,
efficacy, and accessibility. Kymanox was founded in 2004 and
is headquartered in Morrisville, North Carolina USA. For more
information, visit www.kymanox.com.
About Silo Pharma
Silo Pharma. Inc. is a development-stage biopharmaceutical
company focused on merging traditional therapeutics with
psychedelic research for people suffering from indications such as
PTSD, Alzheimer’s disease, and other rare neurological disorders.
Silo’s mission is to identify assets to license and fund the
research which we believe will be transformative to the well-being
of patients and the healthcare industry. For more information visit
www.silopharma.com
Forward-Looking Statements
All statements other than statements of historical fact in this
announcement are forward-looking statements that involve known and
unknown risks and uncertainties and are based on current
expectations and projections about future events and financial
trends that the Company believes may affect its financial
condition, results of operations, business strategy, and financial
needs. Investors can identify these forward-looking statements by
words or phrases such as "may," "will," "expect," "anticipate,"
"aim," "estimate," "intend," "plan," "believe," "potential,"
"continue," "is/are likely to" or other similar expressions. The
Company undertakes no obligation to update forward-looking
statements to reflect subsequent occurring events or circumstances,
or changes in its expectations, except as may be required by law.
Although the Company believes that the expectations expressed in
these forward-looking statements are reasonable, it cannot assure
you that such expectations will turn out to be correct, and the
Company cautions investors that actual results may differ
materially from the anticipated results and encourages investors to
review other factors that may affect its future results in the
Company's filings with the SEC.
Contact
800-705-0120 investors@silopharma.com
Silo Pharma (NASDAQ:SILO)
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부터 5월(5) 2024 으로 6월(6) 2024
Silo Pharma (NASDAQ:SILO)
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부터 6월(6) 2023 으로 6월(6) 2024