Palisade Bio’s Lead Product Candidate, PALI-2108 Demonstrates Potent Anti-Inflammatory Effects in Ex-Vivo Study of Whole Blood Samples Challenged with Pro-Inflammatory Lipopolysaccharide (LPS)
01 Mai 2024 - 2:30PM
Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”
or the “Company”), a biopharmaceutical company focused on
developing and advancing novel therapeutics for patients living
with autoimmune, inflammatory, and fibrotic diseases, announced
today the successful completion of its analysis to determine the
effects of bioactivated PALI-2108 on TNF-α production in a whole
blood (WB) assay. PALI-2108 is Palisade’s orally administered,
locally acting, colon-specific phosphodiesterase-4 (PDE4) inhibitor
prodrug in development for patients affected by UC.
"These important data bolster our confidence in
the robust anti-inflammatory potential of PALI-2108 in the
management of UC," said Dr. Mitch Jones, CMO of Palisade Bio. "The
superior efficacy of PALI-2108, as demonstrated by its lower
half-maximal inhibitory concentration (or IC50) compared to the
approved PDE4 inhibitor apremilast, underscores its potential as a
next-generation therapeutic option for patients with inflammatory
bowel disease."
This study included WB samples from 14
clinically healthy adults (five women and nine men). Twelve samples
meeting the inclusion criteria were included for TNF-α measurement
and calculation of IC50 values. Donor whole blood was treated with
different concentrations of PALI-2108 and two control compounds
known to inhibit the PDE4 pro-inflammatory pathway. Blood was then
challenged with the pro-inflammatory molecule lipopolysaccharide
(LPS). Anti-inflammatory potency was determined by calculating the
IC50 values for TNF-α inhibition.
Findings from the study demonstrated that
PALI-2108 exhibited efficacy in inhibiting TNF-α production induced
by LPS in this ex-vivo peripheral whole blood assay. Pre-treatment
of human whole blood samples with bioactivated PALI-2108 resulted
in a significant reduction in LPS-induced TNF-α production compared
to non-pretreated samples. Specifically, the Company’s proprietary
PDE4 inhibitor, shown to be released by the local bioconversion of
PALI-2108 prodrug in the colon, demonstrated a mean IC50 for TNF-α
inhibition of 0.022 µM, compared to 0.41 µM for apremilast,
showcasing its potent anti-inflammatory activity. The study was
conducted in collaboration with Paraza Pharma, Inc based in
Montreal, QC.
JD Finley, CEO of Palisade Bio, added “Our
team’s exceptional operational execution is driving the clinical
development of PALI-2108 towards our first-in-human study, which is
on track to start later this year. We are committed to advancing
our pioneering research initiatives aimed at improving the lives of
patients suffering from UC and other inflammatory conditions.”
About Palisade Bio
Palisade Bio is a biopharmaceutical company
focused on developing and advancing novel therapeutics for patients
living with autoimmune, inflammatory, and fibrotic diseases. The
Company believes that by using a targeted approach with its novel
therapeutics it will transform the treatment landscape. For more
information, please go to www.palisadebio.com.
Forward Looking Statements
This communication contains “forward-looking”
statements for purposes of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include statements regarding the Company’s intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: the extent of our cash runway; our
ability to successfully develop our licensed technologies;
estimates about the size and growth potential of the markets for
our product candidates, and our ability to serve those markets,
including any potential revenue generated; future regulatory,
judicial, and legislative changes or developments in the United
States (U.S.) and foreign countries and the impact of these
changes; our ability to maintain the Nasdaq listing of our
securities; our ability to build a commercial infrastructure in the
U.S. and other markets; our ability to compete effectively in a
competitive industry; our ability to identify and qualify
manufacturers to provide API and manufacture drug product; our
ability to enter into commercial supply agreements; the success of
competing technologies that are or may become available; our
ability to attract and retain key scientific or management
personnel; the accuracy of our estimates regarding expenses, future
revenues, capital requirements and needs for additional financing;
our ability to obtain funding for our operations; our ability to
attract collaborators and strategic partnerships; and the impact of
the COVID-19 pandemic or any global event on our business, and
operations, and supply. Any statements contained in this
communication that are not statements of historical fact may be
deemed to be forward-looking statements. These forward-looking
statements are based upon the Company’s current expectations.
Forward-looking statements involve risks and uncertainties. The
Company’s actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, the Company’s ability to advance its
nonclinical and clinical programs, the uncertain and time-consuming
regulatory approval process; and the Company’s ability to secure
additional financing to fund future operations and development of
its product candidates. Additional risks and uncertainties can be
found in the Company’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2023, filed with the Securities and
Exchange Commission (“SEC”) on March 26, 2024. These
forward-looking statements speak only as of the date hereof and the
Company expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in the Company’s
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are
based.
Investor Relations ContactJTC
Team, LLCJenene Thomas 833-475-8247PALI@jtcir.com
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