Palisade Bio Announces Enrollment and Dosing of First Patient in LB1148 Dose Optimization Study
11 Maio 2023 - 10:05AM
Palisade Bio, Inc. (Nasdaq: PALI) (the “Company”), a
biopharmaceutical company advancing therapies for acute and chronic
gastrointestinal (GI) complications, today announced the
commencement of patient enrollment and dosing in its dose
optimization study of LB1148.
J.D. Finley, interim Chief Executive Officer of
Palisade Bio commented, “The dose optimization study is designed to
generate valuable pharmacokinetic and pharmacodynamic data across
multiple doses in healthy adult volunteers. We believe the outcome
of this study will add to our growing body of data and provide the
line of sight needed to further guide our LB1148 clinical
development strategy moving forward.”
LB1148 is the Company’s broad-spectrum serine
protease inhibitor which acts to neutralize digestive enzymes,
potentially reducing intestinal damage. 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.
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:
progress of studies, including opening additional clinical trial
sites, timing of results or data, progress and completion of
patient enrollment, including timing thereof and the Company’s
co-development partner’s expectation to complete enrollment;
regulatory progress and strategy, including potential registration
and commercialization of LB1148; the extent of the cash runway; the
closing of the underwritten public offering; and expected proceeds
from financings. 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; the Company’s
ability to achieve additional financing to fund future operations
and the Company’s ability to comply with the continued listing
requirements for Nasdaq. 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
discussions of potential risks, uncertainties, and other important
factors in our subsequent filings with the Securities and Exchange
Commission. 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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