Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-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® 2023 of the
American Association for the Study of Liver Diseases (AASLD), in
Boston, Massachusetts, November 10 – 14. Bexotegrast is an oral,
small molecule, dual selective inhibitor of αvß6 and αvß1 integrins
that is in development for the treatment of idiopathic pulmonary
fibrosis (IPF) and PSC.
The oral presentation titled “Oral αvβ6/αVβ1
Integrin Inhibition in Primary Sclerosing Cholangitis: 12-week
Interim Safety and Efficacy Analysis of INTEGRIS-PSC, A Phase 2a
Trial of Bexotegrast,” will be delivered by Professor Gideon
Hirschfield, M.D., Lily and Terry Horner Chair in Autoimmune Liver
Disease Research, Toronto Centre for Liver Disease.
“We are pleased to be sharing these positive
interim results from the INTEGRIS-PSC trial with the scientific and
medical communities as part of this leading hepatology conference,”
said Éric Lefebvre, M.D., Chief Medical Officer of Pliant.
“Recognizing that no approved treatments are available for patients
with PSC, we look forward to the further investigation of
bexotegrast including 12 week data from the 320 mg dose in the
first quarter of 2024 and 24 week safety data in mid-2024.”
Late-Breaking Oral
PresentationMonday, November 13 5:00 PM ESTOral
αvβ6/αVβ1
Integrin Inhibition in Primary Sclerosing Cholangitis:
12-week Interim Safety and Efficacy Analysis of INTEGRIS-PSC, A
Phase 2a Trial of Bexotegrast (Abstract
#5008)Gideon M. Hirschfield, Kris V. Kowdley, Michael
Trauner, Palak J. Trivedi, Éric A. Lefebvre, Johanna Schaub, Annie
Clark, Theresa Thuener, Hardean E. Achneck, Chris N. Barnes,
Richard Pencek, Aldo J, Montano-Loza, Christopher L. Bowlus,
Christoph Schramm, Cynthia Levy
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, gender, and race. 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 is 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 is the
evaluation of bexotegrast safety and tolerability and the secondary
endpoint is the assessment of pharmacokinetics across the range of
doses. Exploratory endpoints will measure changes in liver fibrosis
markers, ELF and PRO-C3, liver biochemistry and liver imaging.
About Pliant Therapeutics,
Inc.
Pliant Therapeutics is a clinical-stage
biopharmaceutical company focused on discovering and developing
novel therapies for the treatment of fibrosis. 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, a Phase 2b trial of bexotegrast in IPF.
Pliant has also developed PLN-1474, a small molecule, selective
inhibitor of αvß1 integrin for the treatment of nonalcoholic
steatohepatitis, or NASH with liver fibrosis. Pliant has initiated
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
to clinical-stage programs, Pliant currently has a preclinical
program targeting muscular dystrophies. For additional information,
please visit: www.PliantRx.com. Follow us on social
media Twitter, LinkedIn, Facebook and YouTube.
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; the anticipated timing of data and
progress from our clinical studies; including the timing of 12-week
and 24-week data from the 320 mg dose cohort of the INTEGRIS-PSC
Phase 2a trial in the first quarter of 2024 and mid-2024,
respectively. 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, 2023
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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