Palisade Bio (Nasdaq: PALI) Announces Analysis Demonstrating LB1148 Reduced the Extent and Severity of Post-Surgical Intraabdominal Adhesions by 93%
March 16 2022 - 8:00AM
Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage
biopharmaceutical company advancing therapies for acute and chronic
gastrointestinal (GI) complications, announced data from a
Pooled-Analysis of Studies LBS-IST-POI-101 and LBS-POI-201-CN
(PROFILE-CN.) These data are featured today at the Next
Big Thing session of the Society of American
Gastrointestinal and Endoscopic Surgeons (SAGES) 2022 Annual
Meeting, being held in Denver, March 16-19. Highlights
are:
- LB1148 reduced incidence of
adhesions by 72% in patients undergoing bowel resection
- LB1148 reduced extent and severity
of adhesions by 93% in patients undergoing bowel resection
- The incidence of adhesions in the
placebo group was similar to the published incidence (89% and ≥90%
respectively)
- 100% of placebo-treated subjects
underwent a laparoscopic procedure, and 8 of 9 had ≥ 1
adhesions
- 75% of the 8 LB1148-treated subjects
underwent a laparoscopic procedure, and 2 of 6 had ≥ 1 adhesions
- 25% of the 8 LB1148-treated subjects
underwent a laparotomy, and neither formed adhesions
- No drug-related serious adverse
events occurred in the trials
“The pooled results from these studies suggest that LB1148 has
the potential to prevent postoperative adhesions,” said Michael
Dawson, M.D., Chief Medical Officer of Palisade Bio. “There is
significant unmet need to prevent and reduce adhesions, as they are
found in more than 90% of cases after intraabdominal surgery and
patients tend to suffer life-long complications. These data are
promising as we focus on our mission of protecting intestinal
integrity and improving treatment options for patients.”
Studies LBS-IST-POI-101 and LBS-POI-201-CN (PROFILE-CN) assessed
the efficacy of LB1148 to reduce the formation of adhesions in
subjects undergoing abdominal surgery. Study LBS-IST-POI-101 was a
Phase 1, single-center, open-label, study enrolling 11 subjects
undergoing GI surgery. The PROFILE-CN study was a 120-subject Phase
2, randomized, double-blind, placebo-controlled study conducted in
collaboration with co-development partner, Newsoara Biopharma to
evaluate LB1148 for return of GI function in subjects undergoing
planned bowel resection surgery. In both trials, a subset of
subjects went on to have a second surgery (e.g., stoma take down).
In these subjects, adhesions were assessed and quantified at the
time of surgical closure during the initial surgery and at the time
of opening at the subsequent surgical procedure.
“We are excited about this data as they are extremely
encouraging given adhesion prevalence in patients who have
abdominal surgery and the serious complications that can occur such
as small bowel obstruction, infertility, and chronic abdominal
pain. Further, the FDA has recognized the important unmet
need for adhesions therapeutics and granted Fast Track designation
to LB1148 for the reduction of post-surgical intraabdominal and
pelvic adhesions,” said Tom Hallam, Ph.D., Chief Executive Officer
of Palisade Bio. “We believe LB1148 can help reduce adhesions and
reduce adhesions related complications, while potentially driving
down costs for the healthcare system. These studies provide
critically important data as we continue to research the potential
for LB1148 to reduce post-surgical intraabdominal adhesions in our
phase 2 study.”
A total of 3/11 subjects in LBS-IST-POI-101 and 14/120 subjects
in LBS-POI-201-CN underwent a second surgery. Data were pooled from
the two trials and the incidence as well as the extent, and
severity of adhesions were compared for subjects treated with
LB1148 versus placebo.
Conference Call
Stonegate Capital Partners will host a conference call today,
March 16, 2022, 5:30 a.m. Pacific Time/7:30 a.m. Central Time/8:30
a.m. Eastern Time to further discuss the data. You must register
before the webcast to be able to access it. Please click the link
below to register for the webcast:
https://us06web.zoom.us/webinar/register/WN_ThNZHlT4Q9mBMGrMlxabkg
About LB1148
LB1148 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 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 return of normal GI function,
and shorten the duration of costly post-surgery hospital stays.
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 towards 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 return of bowel function
and decrease in 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 chronic disruption of the
gastrointestinal epithelial barrier. For more information, please
go to www.palisadebio.com.
About Newsoara Biopharma
Newsoara is a biotech company based in Shanghai, China with
research laboratories in the Suzhou BioBAY focusing on novel drug
research and development to address unmet medical needs in patients
with various diseases.
Forward Looking StatementsThis communication
contains “forward-looking” statements, including, without
limitation, statements related to expectations regarding Palisade’s
plans for future presentations at investor conferences. 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 Quarterly Report on
Form 10-Q for the quarter ended September 30,
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
Palisade Bio Media Relations Contact:CORE
IRJules Abrahamjulesa@coreir.com917-885-7378
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