Palisade Bio Announces First Patient Enrolled and Dosed in Pivotal Phase 3 Study Evaluating LB1148 for Postoperative Return of Bowel Function
August 17 2022 - 8:35AM
Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage
biopharmaceutical company advancing therapies for acute and chronic
gastrointestinal (GI) complications, today announced the first
patient has been dosed in its Phase 3 study evaluating LB1148 to
accelerate the return of bowel function in adult patients
undergoing gastrointestinal surgery.
Tom Hallam, Ph.D., Chief Executive Officer of
Palisade Bio, commented, “The dosing of our first patient in the
LB1148 Phase 3 marks a noteworthy milestone for the company and
another important step forward in the execution of our strategy.
With what we believe to be a pivotal Phase 3 study now fully
underway, we are focused on building momentum and completing
enrollment as quickly and efficiently as possible. The design of
this Phase 3 study mirrors that of our positive Phase 2 study where
LB1148 demonstrated a statistically significant improvement in the
time of return of bowel function.”
LB1148, the company’s lead asset in development,
is a novel oral liquid formulation of the well-characterized
digestive enzyme inhibitor tranexamic acid, with the potential to
both reduce abdominal adhesions and help restore bowel function
following surgery. LB1148 is currently being developed for
administration prior to surgeries that are at risk of disrupting
the intestinal epithelial barrier.
“LB1148 represents a promising opportunity to
establish the standard of care for accelerating the postoperative
return of bowel function. In my opinion, the data with LB1148 to
date is encouraging and provides a solid foundation as we begin to
dose patients in this phase of development,” added Dr. Soghomonyan,
a (Principal Investigator) at The Ohio State University Wexner
Medical Center.
The Phase 3 study is designed as a multi-center,
randomized, double-blind, parallel-group, placebo-controlled
clinical trial set to enroll approximately 600 patients, which will
assess the safety and efficacy of LB1148. The primary endpoint is
time to recovery of the upper and lower gastrointestinal tract
following surgery, defined as the time from the end of surgery to
the toleration of food and first bowel movement. All patients
enrolled in the study will undergo a scheduled bowel resection
surgery that will include either laparotomy or minimally invasive
surgical approaches. The clinical study will utilize the same
dosing of LB1148 used in the company’s completed Phase 2 study in
which LB1148 demonstrated a 1.1-day improvement in return of bowel
function.
About LB1148LB1148 is an oral formulation of a
broad-spectrum serine protease inhibitor designed to neutralize the
activity of potent digestive proteases released from the gut during
surgery. Evidence suggests that the release of digestive proteases
contributes to the temporary loss of normal gastrointestinal
function and the formation of postoperative adhesions. By
inhibiting the activity of these digestive proteases, LB1148 has
the potential to prevent damage to GI tissues, accelerate the time
to the return of normal GI function, and shorten the duration of
costly post-surgery hospital stays.
About Palisade Bio Palisade Bio is a
late-stage 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 and human
disease to develop 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 which acts to neutralize
digestive enzymes, potentially reducing intestinal damage. In
multiple clinical studies, LB1148 has demonstrated positive results
in accelerating the time to return of postoperative bowel function,
and the Company recently presented analysis that LB1148 reduced the
incidence and severity of post-surgical abdominal adhesions. LB1148
is currently being evaluated in a Phase 3 clinical study for
accelerating the return of postoperative bowel function and in a
Phase 2 study for the prevention of post-surgical abdominal
adhesions.
The Company believes that addressing the
disruption of the intestinal barrier has the potential to
fundamentally change the way diseases are treated and to 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 Palisade’s intentions, beliefs, projections, outlook,
analyses or current expectations concerning, among other things:
the potential to fundamentally change the way diseases are treated,
the completion of enrollment for the Phase 3 study, the potential
for the statistically significant Phase 3 data to allow for NDA
approval, and the potential for LB1148 to establish the standard of
care, if approved. 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 Palisade’s current expectations. Forward-looking
statements involve risks and uncertainties. Palisade’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 clinical
development and the company’s ability to comply with the continued
listing requirements for Nasdaq. Additional risks and uncertainties
can be found in Palisade Bio’s Quarterly Report on Form 10-Q for
the quarter ended June 30, 2022. Palisade 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 Palisade’s expectations with regard thereto
or any change in events, conditions or circumstances on which any
such statements are based.
Palisade Bio Investor Relations Contact:Dawn
Hofmeisterir@palisadebio.com
Investor Relations ContactJTC Team, LLCJenene
Thomas 833-475-8247PALI@jtcir.com
Source: Palisade Bio
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