Palisade Bio Cleared by Health Canada to Commence Phase 1 Clinical Study for Lead Program, PALI-2108 for the Treatment of Ulcerative Colitis (UC)
10 Octobre 2024 - 2:30PM
Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio”
or the “Company”), a biopharmaceutical company focused on
developing and advancing novel therapeutics for patients living
with autoimmune, inflammatory, and fibrotic diseases, today
announced that it has received a No Objection Letter from Health
Canada for its Phase 1 human clinical study for PALI-2108 for the
treatment of UC.
“We are thrilled to receive a No Objection
Letter from Health Canada in response to our Clinical Trial
Application. This achievement marks the most important milestone to
date for our PALI-2108 development program. We continue to believe
in the potential of PALI-2108 to be the first approved PDE4
inhibitor for UC and more importantly, provide a much-needed
effective and safe solution for UC patients still experiencing
significant medical need. Our team remains focused on continuing
preparations for the initiation of our Phase 1 clinical trial which
is on track to commence before year end,” commented J.D. Finley,
Chief Executive Officer.
PALI-2108 is an orally administered PDE4
inhibitor prodrug which is locally bioactivated in the colon and is
in development for patients affected by UC. The Phase 1 study will
evaluate PALI-2108 in a single-center, double-blind,
placebo-controlled study focused on safety, tolerability,
pharmacokinetics, and pharmacodynamics in healthy volunteers,
alongside an open-label study involving a patient cohort with UC.
As previously announced, the Company has established dose levels
and trial design for PALI-2108 and plans to enroll approximately 90
patients across the SAD, FE, MAD and UC cohorts.
“Patients are actively seeking new and more
effective treatment options for their ulcerative colitis.
Currently, existing therapies achieve complete remission in fewer
than a quarter of patients, and many of the most effective
treatments involve injections or carry black box warnings due to
serious side effects. A safe and effective oral medication for UC
would be highly desirable for the majority of patients,” said
Florian Rieder, MD, a member of the Palisade Bio Clinical Advisory
Board and Associate Staff in the Department of Gastroenterology,
Hepatology, and Nutrition, as well as an Investigator in the
Department of Pathobiology at the Cleveland Clinic.
The primary objective of the study will be to
assess the safety and tolerability of single (healthy subjects) and
repeated (healthy subjects and UC patients) oral doses of
PALI-2108. Secondary objectives include determining the plasma,
urinary, and fecal (MAD healthy subjects and UC patients only)
pharmacokinetics (PK) of PALI-2108 and its metabolites following
PALI-2108 single (healthy subjects) and repeated (healthy subjects
and UC patients) oral doses, as well as the effect of food on the
PK of PALI-2108 and its metabolites following a single oral dose in
healthy subjects. Exploratory objectives will include PDE4-related
pharmacodynamic (PD) biomarkers, concentrations of the active form
of PALI-2108, high sensitivity C-reactive protein (hsCRP), fecal
calprotectin (CalPro), colonic tissue Absolute Lymphocyte Count
(ALC), Modified Mayo score, as well as colonic histological changes
in UC patients following repeated PALI-2108 oral doses.
Preparations for the clinical study remain
ongoing and the Company is on track commence site initiation and
enrollment for the study before year end.
About Palisade Bio
Palisade Bio is a biopharmaceutical company
focused on developing and advancing novel therapeutics for patients
living with autoimmune, inflammatory, and fibrotic diseases. The
Company believes that by using a targeted approach with its novel
therapeutics it will transform the treatment landscape. 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: the extent of our cash runway; our
ability to successfully develop our licensed technologies; the
timing and outcome of our current and anticipated applications and
studies related to our product candidates; estimates about the size
and growth potential of the markets for our product candidates, and
our ability to serve those markets, including any potential revenue
generated; future regulatory, judicial, and legislative changes or
developments in the United States (U.S.) and foreign countries and
the impact of these changes; our ability to maintain the Nasdaq
listing of our securities; our ability to build a commercial
infrastructure in the U.S. and other markets; our ability to
compete effectively in a competitive industry; our ability to
identify and qualify manufacturers to provide API and manufacture
drug product; our ability to enter into commercial supply
agreements; the success of competing technologies that are or may
become available; our ability to attract and retain key scientific
or management personnel; the accuracy of our estimates regarding
expenses, future revenues, capital requirements and needs for
additional financing; our ability to obtain funding for our
operations; our ability to attract collaborators and strategic
partnerships; and the impact of the COVID-19 pandemic or any global
event on our business, and operations, and supply. 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 nonclinical and clinical programs, the
uncertain and time-consuming regulatory approval process; and the
Company’s ability to secure additional financing to fund future
operations and development of its product candidates. Additional
risks and uncertainties can be found in the Company’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2023 and most
recent Quarterly Report on Form 10-Q for the period ended June 30,
2024, filed with the Securities and Exchange Commission on March
26, 2024 and August 12, 2024, respectively. 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 Contact
JTC Team, LLCJenene Thomas 908-824-0775PALI@jtcir.com
Palisade Bio (NASDAQ:PALI)
Graphique Historique de l'Action
De Nov 2024 à Déc 2024
Palisade Bio (NASDAQ:PALI)
Graphique Historique de l'Action
De Déc 2023 à Déc 2024