Palisade Bio Announces Positive Data from Two Ex Vivo Translational Studies of PALI-2108 for the Treatment of Ulcerative Colitis
31 Outubro 2024 - 9:30AM
Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or
the “Company”), a biopharmaceutical company dedicated to developing
novel therapeutics for patients with autoimmune, inflammatory, and
fibrotic diseases has announced the presentation of data from two
translational studies demonstrating the ex vivo bioactivation of
PALI-2108 in stool samples and whole blood. This orally
administered, colon-specific phosphodiesterase-4 (PDE4) inhibitor
prodrug is in development for patients with ulcerative colitis
(UC).
The poster titled “Colonic Bioactivation and
Potent TNFα Inhibition of PALI-2108 in Human Clinical Studies: A
Promising PDE4 Inhibitor Prodrug for the Oral Treatment of
Ulcerative Colitis,” was presented by Dr. Mitch Jones, Chief
Medical Officer of Palisade Bio, at the ACG 2024 Annual Scientific
Meeting, held October 25-30, 2024, in Philadelphia, PA.
“The design of PALI-2108 ensures that activation
is targeted primarily in the colon, which should minimize systemic
exposure and potential central nervous system side effects. By
demonstrating reduced systemic exposure, we believe PALI-2108 can
effectively address the toxicity issues commonly associated with
other PDE4 inhibitors like roflumilast and apremilast,” stated Dr.
Mitch Jones, CMO of Palisade. “These ex vivo data reinforce the
potential of PALI-2108 as an innovative therapeutic option for
managing UC. We remain committed to advancing toward the launch of
our Phase 1 study and are excited to further explore the potential
of this novel, orally delivered, intestinally activated PDE4
inhibitor prodrug.”
Researchers assessed prodrug conversion in stool
samples from six healthy individuals and six patients with UC using
liquid chromatography-mass spectrometry (LC-MS). The enzymatic
activity was evaluated by measuring the half-lives of samples from
each donor. PALI-2108 was spiked into stool homogenates at a
concentration of 100 μM, followed by a 24-hour incubation
period.
Additionally, the impact of the active
phosphodiesterase 4 (PDE4) inhibitor, PALI-0008, on
lipopolysaccharide (LPS)-induced tumor necrosis factor-alpha (TNFα)
production was investigated through an ex vivo assay using
peripheral whole blood. Whole blood from twelve healthy human
donors was pre-treated with PALI-0008 before being challenged with
LPS at 1 µg/ml for 24 hours. TNFα production was quantified, and
the IC50 values for apremilast and PALI-2108 were calculated.
Furthermore, a microbiome study was conducted in
collaboration with CosmosID to evaluate the abundance of the
beta-glucuronidase enzyme in microbiome samples from mice, dogs,
healthy humans, and UC patients. Publicly available data for dog,
mouse, and human whole genome metagenomic sequencing were obtained
from the NCBI Sequence Read Archive. These samples were uploaded to
the CosmosID-HUB (app.cosmosid.com) for functional identification
of genes, enzymes, and pathways, utilizing MetaCyc, Gene Ontology,
and Enzyme Commission databases.
Key Highlights
- PALI-2108 was successfully
bioactivated into its active form, PALI-0008, in stool samples from
both normal healthy volunteers (NHV) and UC patients, achieving a
high conversion rate of 90.1% at 24 hours.
- PALI-0008 demonstrated significant
inhibition of TNFα production in human whole blood, with an IC50 of
0.022 μM, indicating strong potency.
- PALI-0008 exhibited approximately a
20-fold higher potency in reducing TNFα production compared to
apremilast, underscoring its potential efficacy.
- The microbiome study revealed
consistent levels of β-glucuronidase across different species and
conditions, supporting the activation mechanism of PALI-2108.
- The consistent abundance of this
enzyme suggests that PALI-2108 could be effective across diverse
patient populations, including those with UC.
The Company is advancing PALI-2108 toward a
Phase 1 single-center, double-blind, placebo-controlled study
focused on safety, tolerability, pharmacokinetics, and
pharmacodynamics in healthy volunteers, alongside an open-label
study involving UC patients. Preparations for the clinical study
are ongoing, and the Company is on track to initiate patient dosing
before year-end. For more information about the Company’s
next-generation precision therapies for immune, inflammatory, and
fibrotic diseases, please visit palisadebio.com.
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; the
timing and outcome of our current and anticipated applications and
studies related to our product candidates; 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 and most
recent Quarterly Report on Form 10-Q for the period ended June 30,
2024, filed with the Securities and Exchange Commission on March
26, 2024 and August 12, 2024, respectively. 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 Contact
JTC Team, LLCJenene Thomas 908-824-0775PALI@jtcir.com
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