Palisade Bio’s LB1148 Two Ongoing Clinical Trials Expecting Topline Data Readouts
May 24 2023 - 8:45AM
Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the
“Company”), a biopharmaceutical company advancing therapies for
acute and chronic gastrointestinal (GI) complications, today
provided a clinical program update for its lead product candidate,
LB1148, a broad-spectrum serine protease inhibitor which acts to
neutralize digestive enzymes, potentially reducing intestinal
damage.
“We remain focused on our U.S. Phase 2 adhesions
study with our lead drug, LB1148, and look forward to our data
readout in the coming weeks. We believe the topline data from our
Phase 2 study will provide valuable insight related to future trial
design,” commented J.D. Finley, interim Chief Executive Officer.
“Additionally, we have made rapid progress in our dose optimization
study. We have already dosed eight patients and remain on track to
have that topline data in the third quarter of this year.”
“We continue to believe there is great potential
for LB1148 to fundamentally transform the way physicians mitigate
the risks of acute and chronic GI complications from surgery. We
are grateful for the continued support of all our stakeholders and
look forward to the continued advancement of LB1148,” concluded Mr.
Finley.
U.S. Phase 2 Adhesions Study
LB1148 is currently being evaluated in a Phase 2
study for its effectiveness in reducing intra-abdominal adhesions,
accelerating return of gastrointestinal function, and the
prevention of post-operative ileus in patients undergoing elective
bowel resection (PROFILE).
Many of the patients enrolled in PROFILE have
cancer, and most continue adjuvant therapy after completing the
initial surgery. Once the patient has been treated and cleared for
surgery, the second surgery is scheduled. Per the clinical trial
protocol, the patient has up to eight months from the initial
surgery to complete the second surgery, and the last patient out is
expected on or before June 24, 2023. The Company expects to report
topline data within four weeks following the last surgery.
Dose Optimization Study
The Company recently commenced patient
enrollment and dosing in its ongoing dose optimization study. The
dose optimization study is being conducted to determine if a
different dosing protocol might enhance the risk profile while
simultaneously providing efficacy for the development program
moving forward. The study is expected to enroll approximately 32
healthy subjects. To date eight subjects, or 25%, have been
enrolled and dosed. The Company expects to complete enrollment and
report topline data in Q3 2023.
About Palisade
Bio Palisade Bio is a biopharmaceutical company
focused on developing therapeutics that protect the integrity of
the intestinal barrier. The Company utilizes over three decades of
research and established science that links the role of intestinal
barrier biology with human disease to advance novel therapeutics
that target and improve the integrity of the intestinal
barrier.
The Company’s lead program, LB1148, is a
broad-spectrum serine protease inhibitor that acts to neutralize
digestive enzymes, potentially reducing intestinal damage. In prior
clinical studies, LB1148 has demonstrated positive results in
reducing the incidence and severity of post-surgical abdominal
adhesions and potentially reducing the time to return of
postoperative bowel function. LB1148’s current U.S. Phase 2 study
is evaluating its effectiveness in reducing intra-abdominal
adhesions, accelerating return of gastrointestinal function, and
the prevention of post-operative ileus in subjects undergoing
elective bowel resection (PROFILE).
The Company believes that addressing the
disruption of the intestinal barrier can fundamentally change the
way diseases are treated and establish new standards of patient
care. 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; 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 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 additional 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 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
clinical programs, the uncertain and time-consuming regulatory
approval process; and the Company’s ability to achieve additional
financing to fund future operations. 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. 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 833-475-8247PALI@jtcir.com
Source: Palisade Bio
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