Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage
biotechnology company and leader in the discovery and development
of novel therapeutics for the treatment of fibrotic diseases, today
announced a late-breaking presentation of results from the
INTEGRIS-PSC Phase 2a trial of bexotegrast in patients with primary
sclerosing cholangitis (PSC) at The Liver Meeting® 2024 of the
American Association for the Study of Liver Diseases (AASLD), in
San Diego, California November 15 – 19. Bexotegrast is an oral,
small molecule, dual selective inhibitor of αvß6 and αvß1 integrins
that is being studied for the treatment of idiopathic pulmonary
fibrosis (IPF) and PSC.
The oral presentation titled “Bexotegrast, an oral inhibitor of
αvβ6 and αvβ1 integrins, was shown to improve markers and symptoms
of cholestasis and stabilized markers of liver fibrosis in
participants with primary sclerosing cholangitis: Week 24 results
from the Phase 2 INTEGRIS-PSC trial,” will be delivered by Kris
Kowdley M.D., AGAF, FAASLD, FACP, FACG, Director, Liver Institute
Northwest and Professor of Medicine, Elson S. Floyd College of
Medicine at Washington State University.
Late-Breaking Oral Presentation
Title: Bexotegrast, an oral inhibitor of αvβ6
and αvβ1 integrins, was shown to improve markers and symptoms of
cholestasis and stabilized markers of liver fibrosis in
participants with primary sclerosing cholangitis: Week 24 results
from the Phase 2 INTEGRIS-PSC trialPresenter: Kris
Kowdley, M.D.Session: Late Breaking Abstract
Parallel Session 1Session Time: November 18, 2024,
2:00 p.m. - 3:30 p.m. PSTPresentation Time:
November 18, 2024, 3:00 p.m. - 3:15 p.m. PSTPublication
Number: 5004
The late breaker poster will be made available on the
Publications page of the Pliant website at the time of
presentation.
Background on Primary Sclerosing
Cholangitis
PSC is a rare, progressive liver disease of unknown origin,
which frequently occurs in the setting of inflammatory bowel
disease. PSC affects more than 30,000 patients in the United States
and over 100,000 patients worldwide. The disease can occur in all
ages, genders, and races. PSC is characterized by inflammation and
fibrosis, with progressive liver and biliary damage leading to
cirrhosis and liver failure. Currently there are no FDA or
EMA-approved therapies for patients with PSC. Therefore, there is a
high unmet need for new therapeutic options to address the symptoms
and modify the disease progression of this grievous illness.
INTEGRIS-PSC Multinational Phase 2a Trial of Bexotegrast
(NCT04480840)
INTEGRIS-PSC was a Phase 2a, randomized, dose-ranging,
double-blind, placebo-controlled trial evaluating the safety,
tolerability, and pharmacokinetics of bexotegrast administered over
12 weeks in patients with IPF. Patients were enrolled in doses of
40 mg, 80 mg, 160 mg or 320 mg, with a 3:1 randomization ratio
(active:placebo) and stratification based on use of ursodeoxycholic
acid (UDCA). The primary endpoint was the evaluation of bexotegrast
safety and tolerability, and the secondary endpoint is the
assessment of pharmacokinetics across the range of doses.
Exploratory endpoints measured changes in liver fibrosis markers,
enhanced liver fibrosis (ELF) and PRO-C3, liver biochemistry and
liver imaging.
About Pliant Therapeutics, Inc.
Pliant Therapeutics is a late-stage biopharmaceutical company
and leader in the discovery and development of novel therapeutics
for the treatment of fibrotic diseases. Pliant's lead product
candidate, bexotegrast (PLN-74809), is an oral, small molecule,
dual selective inhibitor of αvß6 and αvß1 integrins that is in
development in the lead indications for the treatment of idiopathic
pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or
PSC. Bexotegrast has received Fast Track Designation and Orphan
Drug Designation from the U.S. Food and Drug Administration (FDA)
in IPF and PSC and Orphan Drug Designation from the European
Medicines Agency in IPF and PSC. Pliant has initiated BEACON-IPF,
an adaptive Phase 2b/3 trial of bexotegrast in IPF. Pliant is
conducting a Phase 1 study for its third clinical program,
PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and
αvß1 integrins, that is being developed for the treatment of solid
tumors. In addition, Pliant has received regulatory clearance for
the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody
agonist of integrin α7β1 targeting muscular dystrophies.
For additional information, please visit: www.PliantRx.com.
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Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Words such as "may," "will," "expect," "anticipate,"
"estimate," "intend," and similar expressions (as well as other
words or expressions referencing future events, conditions, or
circumstances) are intended to identify forward-looking statements.
These statements include those regarding the safety, tolerability,
pharmacodynamics and therapeutic potential of bexotegrast; our
plans for the future development of bexotegrast; bexotegrast’s
potential to become a treatment for IPF or PSC. Because such
statements deal with future events and are based on our current
expectations, they are subject to various risks and uncertainties
and actual results, performance or achievements of Pliant
Therapeutics could differ materially from those described in or
implied by the statements in this press release. These
forward-looking statements are subject to risks and uncertainties,
including those related to the development and commercialization of
our product candidates, including any delays in our ongoing or
planned preclinical or clinical trials, the impact of current
macroeconomic and marketplace conditions, our reliance on third
parties for critical aspects of our development operations, the
risks inherent in the drug development process, the risks regarding
the accuracy of our estimates of expenses and timing of
development, our capital requirements and the need for additional
financing, including the availability of additional term loans
under our loan facility, and our ability to obtain and maintain
intellectual property protection for our product candidates. These
and additional risks are discussed in the sections titled "Risk
Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" in our Quarterly Report on
Form 10-Q for the period ended June 30, 2024 which is available on
the SEC's website at www.sec.gov. Unless otherwise noted, Pliant is
providing this information as of the date of this news release and
does not undertake any obligation to update any forward-looking
statements contained in this document as a result of new
information, future events or otherwise.
Investor and Media Contact:
Christopher KeenanVice President, Investor Relations and
Corporate CommunicationsPliant Therapeutics,
Inc.ir@pliantrx.com
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