Silo Pharma Successfully Completes First Phase of Dose-Ranging Study of SPC-15 an Intranasal Treatment for PTSD
January 04 2024 - 8:55AM
Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company”), a
developmental stage biopharmaceutical company focused on merging
traditional therapeutics with psychedelic research, today provided
an update on its previously announced dose-ranging study of SPC-15,
a targeted prophylactic treatment for post-traumatic stress
disorder (PTSD). The purpose of the study is to identify the
maximum tolerated intranasal dose of the drug and pharmacokinetic
in small animals to determine the therapeutically relevant dose
range with the goal of bringing us closer to human trials.
The six- to eight-week non-GLP study includes single ascending
dose evaluation (phase 1) and a 7-day repeat intranasal dose
toxicity and pharmacokinetic study. In the first phase of the
study, all of the animals appeared to tolerate the intranasal
dosing procedure well, with minimal struggling and no sneezing
observed. The final validation report is expected in the first
quarter of 2024.
Eric Weisblum, Chief Executive Officer of Silo Pharma, commented
“There have been no adverse clinical observations reported to date
for this study, which began in late November 2023 and will conclude
in first quarter 2024. If successful, this non-GLP study will be
followed by a GLP safety and toxicology study, both of which will
be utilized in connection with filing an expected Investigational
New Drug (IND) application with the FDA.”
Pre-clinical data has shown that SPC-15 has additive benefits
for combating stress-induced pathophysiology, both at the
behavioral and neural levels. Pre-clinical collaborative work with
Columbia University will be coupled with published preclinical data
in a pre-IND application to the FDA, which the Company expects to
submit during the first quarter of 2024.
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.
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
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