Palisade Bio Announces Positive Preclinical Data of Lead Program PALI-2108 at the 2024 Crohn’s & Colitis Congress
January 29 2024 - 8:05AM
Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the
“Company”), a biopharmaceutical company focused on developing novel
therapeutics for serious chronic gastrointestinal (GI) diseases,
today announced the presentation of positive preclinical data of
its lead asset, PALI-2108 at the Crohn’s & Colitis Congress,
which was held on January 25-27, 2024 in Las Vegas, NV.
The preclinical data was presented in a poster
titled, Local Bioactivation and Efficacy of PALI-2108: A Promising
PDE4 Inhibitor Prodrug for Ulcerative Colitis Treatment. PALI-2108
is the Company’s orally administered, locally acting colon-specific
phosphodiesterase-4B (PDE4B) inhibitor prodrug in development for
patients affected by moderate-to-severely active ulcerative colitis
(UC). The poster is available on the Scientific Publications page
of the Company’s website.
Mitchell Jones, M.D., Ph.D., Chief Medical
Officer of Palisade Bio, commented, “PALI-2108 continues to
demonstrate promise as a novel therapy for UC, with colon-selective
bioactivation, an expanded therapeutic window, reduced CNS
toxicity, potent PDE4 inhibitory activity, and impressive efficacy
in preclinical models. We are pleased with our growing body of
evidence, including support for a precision medicine approach and
the selection of potential responders, which validate the continued
development of this program. We are working diligently to launch
our Phase 1 study later this year, and we are eager to continue to
gain experience on the potential of this groundbreaking PDE4
inhibitor prodrug therapy. The journey ahead holds great promise
for advancing UC treatment, and we are committed to making a
meaningful impact for patients.”
The results presented at the Crohn’s and Colitis
Foundation include several preclinical studies of PALI-2108, a
novel oral PDE4 inhibitor prodrug designed for the treatment of
ulcerative colitis (UC). The Company’s research has focused on
addressing the limitations of current PDE4 inhibitors, such as CNS
toxicity and systemic distribution, which often lead to therapy
discontinuation.
In preclinical studies, PALI-2108 demonstrated
promising outcomes. In a DSS-induced UC mouse model, researchers
observed a significant reduction in disease activity index (DAI)
score over time compared to the control group. Notably, body weight
loss was attenuated in specific dosage groups, showcasing the
potential for targeted efficacy.
PALI-2108's unique design, incorporating a
galactose-derived sugar moiety, allows for minimal absorption until
cleaved by the colonic bacterium enzyme β-glucuronidase. This
feature ensures localized bioactivation, leading to colon-specific
distribution with limited systemic exposure, as confirmed by a
tissue distribution study. The colon/plasma AUC ratio exceeding 200
further highlights PALI-2108's preference for the colon.
In addition, the Company’s research demonstrates
colon-selective bioactivation in oxazolone colitis-induced mice,
negligible plasma levels in duodenal and ileal tissue, and
comparable target engagement with other PDE4 inhibitors. As well, a
tolerated dose study in dogs revealed no CNS toxicity or emesis
over effective doses, addressing a critical concern associated with
oral administration.
“PALI-2108 is emerging as a promising candidate
for UC therapy, offering localized bioactivation, expanded
therapeutic window, and potent PDE4 inhibitory activity. We believe
this innovative approach has the potential to revolutionize UC
treatment and enhance patient outcomes,” added Dr. Jones.
In summary, results of the Company’s preclinical
studies showed that PALI-2108 demonstrated:
- Local bioactivation;
- Colon-specific distribution;
- Similar target engagement to other
PDE4 inhibitors;
- Dose-dependent efficacy in a mouse
UC model; and
- No systemic toxicity in dogs and
large therapeutic window due to local activation.
Inflammatory bowel disease (IBD) represents a
multi-billion-dollar market opportunity in need of innovative
approaches, with current therapies achieving a clinical remission
rate of less than 20% on average.
About Palisade BioPalisade Bio
is a biopharmaceutical company focused on developing novel
therapeutics for serious chronic gastrointestinal 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 StatementsThis
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, 2022, filed
with the Securities and Exchange Commission (“SEC”) on March 22,
2023, as well as the Company’s Quarterly Report on Form 10-Q, for
the three and nine month periods ended September 30, 2023, filed
with the SEC on November 9, 2023. 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
Source: Palisade Bio
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