Palisade Bio Provides Business Outlook and Highlights Expected Near-Term Pipeline Advancements
May 02 2022 - 8:35AM
Palisade Bio (Nasdaq: PALI), a clinical stage
biopharmaceutical company advancing therapies for acute and chronic
gastrointestinal (GI) complications, today provided a business
outlook and outlined its expected near-term pipeline advancements.
“The positive data we have amassed continues to
support our development strategy and provides us with confidence as
we advance our lead program into a Phase 3 study this quarter. Each
day that a patient remains in the hospital can cost upwards of
approximately $2,400, representing a significant burden on the cost
of healthcare. We believe, if approved, LB1148 will protect
gastrointestinal integrity and accelerate the return of
postoperative GI function, providing hospitals with a potentially
safe solution to accelerate patient discharge. Additionally, LB1148
has the potential to reduce abdominal adhesions – a problem that
can cause an alarming number of post-surgery complications. With
our data in hand, we have aligned on a strategy for LB1148 to
transform the current standard of care which will allow us to
unlock significant value for our shareholders,” commented Tom
Hallam, Ph.D., Chief Executive Officer of Palisade Bio.
Clinical Program Update
LB1148: oral formulation of a broad-spectrum
serine protease inhibitor designed to neutralize the activity of
potent digestive proteases released from the gut during surgery
LB1148 is a novel oral liquid formulation of the
well-characterized digestive enzyme inhibitor, tranexamic acid
(“TXA”), with potential to both reduce abdominal adhesions and help
restore bowel function following surgery. The therapy is being
developed for administration prior to major surgeries that are at
risk of disrupting the intestinal epithelial barrier. 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.
Postoperative Return of Bowel Function: GI
Surgery
In March 2022, the Company received a “Study May
Proceed” letter from the U.S. Food and Drug Administration (FDA) to
initiate its Phase 3 clinical trial evaluating LB1148 to accelerate
the return of bowel function in adult patients undergoing
bowel/abdominal surgery. The trial is designed as a multi-centered,
randomized, double-blinded, parallel-group, placebo-controlled
clinical trial set to enroll approximately 600 patients, and will
assess the safety and efficacy of LB1148. All patients enrolled in
the trial will undergo a scheduled bowel resection surgery that
will include either laparotomy or laparoscopic surgical
approaches.
The expected timelines are management’s current
forecasts and will be updated as enrollment progresses.
Expected Upcoming Milestones
- Q2 2022: Phase 3 study
initiation
- 2H 2022: Phase 3 study first
patient enrolled
Prevention of Post-Surgical Abdominal Adhesions:
GI Surgery
Digestive enzymes can escape the intestine
during major surgery and cause damage to the intestines and
surrounding organs resulting in the formation of scar tissue known
as adhesions. Adhesion prevalence has historically reported to be
>90% in patients who undergo abdominal surgery and represents a
potentially significant contribution to serious complications.
Adhesions can be the cause of chronic pain and may prevent normal
organ function, including bowel obstructions of the intestine.
Adhesions can increase the difficulty of subsequent surgeries
causing complications and are the leading cause of secondary
infertility in women. In some cases, adhesions require a second
corrective surgical procedure. There are currently no approved
medications to prevent or treat adhesions.
Previously the Company had just three patients
who had been assessed for adhesions following GI surgery. In the
Company’s recent data presentation at the Society of American
Gastrointestinal and Endoscopic Surgeons (SAGES) 2022 Annual
Meeting, a pooled-study analysis of 17 patients demonstrated LB1148
reduced incidence of adhesions by 72% and reduced the extent and
severity of adhesions by 93% in patients undergoing bowel
resection.
The Company is conducting an ongoing randomized,
double-blind, placebo-controlled, parallel-group, multicenter Phase
2 clinical trial of LB1148 in up to 200 patients undergoing
elective bowel resection surgery in the United States. This trial
is designed to evaluate whether patients treated with LB1148
experience fewer postoperative intra-abdominal adhesions. The trial
will also assess LB1148’s impact on recovery of GI function, as
compared to placebo.
Expected Upcoming Milestones
- Q4 2022: Phase 2 enrollment
completion
- 1H 2023: Phase 2 study
completion
- 2H 2023: Report Phase 2 topline
results
Postoperative Return of Bowel Function:
Cardiovascular Surgery
The Company previously announced positive
topline data from its Phase 2 study demonstrating LB1148 achieved
its primary endpoint with statistically significant improvement in
bowel function following cardiovascular surgery. The Phase 2
clinical trial was a randomized, double-blind, parallel,
placebo-controlled trial in 120 subjects undergoing coronary artery
bypass grafting (CABG) and/or heart valve replacement surgery
requiring cardiopulmonary bypass (CPB) with patients randomized to
receive LB1148 or placebo in conjunction with surgery. LB1148
provided a 30% improvement in the time to normal bowel function
following cardiovascular surgery (p<0.001) compared to placebo.
This improvement resulted in a 1.1-day reduction in average length
of stay in the ICU and a 1.0-day reduction in average hospital
length of stay. LB1148 was also shown to be safe and well-tolerated
in the study.
The Company plans to initiate additional CV
surgery studies with LB1148 after the completion of the studies to
accelerate the return of bowel function in patients undergoing
bowel/abdominal surgery.
The U.S. FDA has previously granted Fast Track
designation to LB1148 for two clinical indications: reduction of
adhesions following abdominal or pelvic surgery and treatment of
postoperative GI dysfunction in pediatric patients undergoing
cardiac surgery.
About Palisade
Bio Palisade Bio is a clinical stage
biopharmaceutical company advancing therapies that aid patients
suffering with acute and chronic gastrointestinal complications
stemming from post-operative digestive enzyme damage. Palisade
Bio’s innovative lead asset LB1148, advancing toward Phase 3, is a
protease inhibitor with the potential to both reduce abdominal
adhesions and help restore bowel function following surgery.
Positive data from Phase 2 trials of LB1148 demonstrated safety and
tolerability as well as a statistically significant improvement in
the return of bowel function and a decrease in the length of stay
in ICU and hospital compared to placebo. Palisade Bio believes that
its investigational therapies have the potential to address the
myriad health conditions and complications associated with the
chronic disruption to the gastrointestinal epithelial barrier. For
more information, please go to www.palisadebio.com.
Forward Looking StatementsThis
communication contains “forward-looking” statements, including,
without limitation, statements related to its expected near-term
pipeline advancements and milestones, expectations regarding
regulatory submissions, the potential for LB1148 to transform the
current standard of care, if approved and the ability for the
Company to unlock significant value for our shareholders. 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 and the uncertain and
time-consuming regulatory approval process. Additional risks and
uncertainties can be found in Palisade Bio’s Annual Report on Form
10-K for the year ended December 31, 2021. 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
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