Silo Pharma to Initiate Dose-Ranging Study of Novel Intranasal Therapeutic SPC-15 for the Treatment of PTSD
08 11월 2023 - 10:11PM
Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a
developmental stage biopharmaceutical company focused on merging
traditional therapeutics with psychedelic research, today announced
plans to initiate a dose-ranging study of its targeted prophylactic
treatment SPC-15 for the treatment of post-traumatic stress
disorder (PTSD). The study will identify the maximum tolerated
intranasal dose of the drug and pharmacokinetic in small animals to
determine the therapeutically relevant dose range.
In collaboration with AmplifyBio, Silo Pharma’s contract
research organization (CRO) partner, the six- to eight-week
non-good laboratory practice (GLP) study will include single
ascending dose evaluation (phase 1) and a 7-day repeat intranasal
dose toxicity and pharmacokinetic study. The final validation
report is expected in 2024.
“Determining the dose range that should be studied is an
important step before taking a new drug candidate into a
first-in-human trial,” said Eric Weisblum, Chief Executive Officer
of Silo Pharma. “Completion of this study, along with our recently
announced human factor study, is expected to give us an early
start on our goal of a Phase 1 clinical trial of 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.
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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