Palisade Bio Announces Topline Results from U.S. Phase 2 PROFILE Study Evaluating LB1148 for Post-Surgical Abdominal Adhesions
09 Agosto 2023 - 9:05AM
Palisade Bio (Nasdaq: PALI), a biopharmaceutical company advancing
therapies for acute and chronic gastrointestinal (GI)
complications, today reported that the Company’s U.S. Phase 2
PROFILE study evaluating LB1148 for reduction in intra-abdominal
adhesions in subjects following elective bowel resection did not
achieve its primary endpoint.
“First and foremost, I would like to extend our
appreciation to all of the study participants, the clinical staff
at the study sites, as well as our team. The PROFILE study has
provided us with a definitive outcome and enabled us to quickly
make the decision to no longer pursue the adhesions indication,”
commented J.D. Finley, Chief Executive Officer of Palisade Bio.
“Moving forward, we remain committed to the future of Palisade and
are in the midst of encouraging discussions that we believe will
lead to pipeline expansion opportunities in high value indications
in the GI space. Our focus is now on completing these discussions
in order to unlock opportunities and provide value for our
shareholders.”
PROFILE Study Design
The Company’s U.S. Phase 2 clinical trial of
LB1148 was a randomized, double-blind, placebo-controlled,
parallel-group, multicenter study in patients undergoing elective
bowel resection surgery. This trial was originally designed to
evaluate whether patients treated with LB1148 would accelerate the
return of GI function in subjects undergoing elective bowel
resection with or without a planned stoma. The study commenced in
October 2019 and was paused in July 2020 due to COVID-19. During
that timeframe, 79 patients were enrolled. The study was restarted
in May 2022, where the protocol was amended to evaluate whether
patients treated with LB1148 would experience reduction in
formation of post-surgical intra-abdominal adhesions in subjects
undergoing elective bowel resection with planned stoma take-down.
The study enrolled an additional 35 of the planned 70 patients
under this amended protocol.
Primary Endpoint
Of the patients enrolled as of May 10, 2023, 31
patients completed a first surgery, and 22 patients completed a
second surgery, which is required to evaluate the primary endpoint.
Topline data demonstrated that LB1148 did not achieve the primary
endpoint of reducing adhesions in LB1148 treated patients (n=11)
compared to placebo treated patients (n=11) post bowel resection
surgery.
Safety
There were 30 serious adverse events (SAEs),
with 16 SAEs reported in the LB1148 group (3 related to LB1148)
versus 14 in the placebo group.
Conclusion
The Company does not believe the safety data and
efficacy results of the Phase 2 PROFILE trial support further
development of LB1148 for reduction in intra-abdominal
adhesions.
For complete PROFILE study details, please visit
clinicaltrials.gov and reference identifier NCT02836470.
Pipeline Expansion
Opportunities
Palisade remains focused on the development of
novel therapeutics that target and improve the integrity of the
gastrointestinal barrier. Management has ongoing business and
corporate development initiatives to identify synergistic
technologies to expand its pipeline. The Company has been working
to identify opportunities to acquire and or in-license development
programs within the GI space and is engaged in active discussions.
The Company expects to provide an update on these efforts if formal
agreements are reached.
About Palisade Bio
Palisade Bio is a biopharmaceutical company
focused on developing therapeutics that protect the integrity of
the intestinal barrier. 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 Statements
This 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 its product
candidates; the extent of the cash runway; and the ability to
diversify the Company’s product pipeline. 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, Quarterly Report on Form 10-Q
for the quarter ended March 31, 2023, filed with the SEC on May 11,
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
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