Pliant Therapeutics Presents Data from its Bexotegrast Program at the European Association for the Study of the Liver (EASL) International Liver Congress™
June 23 2023 - 7:30AM
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage
biotechnology company focused on discovering and developing novel
therapeutics for the treatment of fibrosis, today announced that it
presented Phase 2a clinical data and preclinical data of
bexotegrast (PLN-74809) program this week as part of the European
Association for the Study of the Liver (EASL) International Liver
Congress™ 2023, held June 21- 24, 2023. Bexotegrast, is an oral,
small molecule, dual-selective inhibitor of αvβ6 and αvβ1 integrins
being developed for the treatment of idiopathic pulmonary fibrosis
and primary sclerosing cholangitis (PSC).
“PSC is a rare chronic autoimmune disease with no effective
therapy, representing a large unmet need for new treatments. Our
presentations this week discuss the early non-clinical work that
support our ongoing Phase 2a clinical program. We look forward to
sharing interim data from this trial in the third quarter,” said
Éric Lefebvre, M.D., Chief Medical Officer at Pliant
Therapeutics.
INTEGRIS-PSC Phase 2a Study: Evaluating the Safety,
Tolerability, and Pharmacokinetics of Bexotegrast (PLN-74809) in
Participants with Primary Sclerosing Cholangitis
The study design, baseline demographics and blinded safety data
from the 85 participants randomized into the 40, 80 and 160 mg dose
cohorts or placebo was presented from the ongoing INTEGRIS-PSC
Phase 2a study. This study is evaluating the safety, tolerability,
and pharmacokinetics of bexotegrast in PSC.
Twelve-week data from this study is expected in the third
quarter of 2023. Following a positive independent Data Safety
Monitoring Board (DSMB) safety review in the first quarter,
enrollment commenced in a Phase 2a trial of bexotegrast at 320 mg
dosed once daily for at least 24 weeks, and up to 48 weeks, in
patients with PSC.
The following posters were selected for inclusion in EASL’s
Session Poster Tours.
Dual alpha-v/beta-6 and alpha-v/beta-1 Integrin
Inhibitor Bexotegrast Attenuates Profibrogenic Gene Expression of
Myofibroblasts in Human Liver Explant Tissue with Biliary
Fibrosis
The effects of bexotegrast on individual cell populations were
evaluated in fibrotic PSC and primary biliary cholangitis (PBC)
precision-cut liver slices. Treatment with bexotegrast resulted in
clear reductions in profibrogenic gene expression across multiple
pathologic cell populations with a similar degree of reduction in
profibrogenic gene expression seen compared to a TGF-β receptor I
kinase inhibitor. These results suggest an important role for the
integrin-TGF-β activation pathway in fibrotic biliary diseases and
are consistent with the anti-fibrotic mechanism of action of
bexotegrast.
Non-invasive Imaging Method Demonstrates Anti-fibrotic
Efficacy of a Dual Integrin alpha-v/beta-6 and alpha-v/beta-1
Inhibitor in a Rat Model of Biliary Fibrosis
PET and molecular MRI were used to non-invasively monitor the
effects of αvβ6 and αvβ1 antagonism in a rat model of biliary
fibrosis. Results showed changes in target expression and fibrosis
in response to bile duct injury and treatment with a dual integrin
αvβ6/αvβ1 antagonist that were confirmed by classic histological
analysis. These data support the antifibrotic effect of dual
αvβ6/αvβ1 integrin inhibition in biliary fibrosis.
Posters presented at the 2023 EASL Conference are available
under the Publications section on Pliant’s website
at https://pliantrx.com/publications.
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 future development
of bexotegrast and timing of future data from our clinical
programs. 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 the COVID-19 pandemic on our business, operations,
clinical supply and plans, 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, 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
Annual Report on Form 10-K for the year ended December 31, 2022, as
updated by our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2023, which are 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.
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 is currently conducting a Phase 2a
trial of bexotegrast in the PSC and is planning a Phase 2b trial in
IPF. Pliant has also developed PLN-1474, a small molecule,
selective inhibitor of αvß1 for the treatment of nonalcoholic
steatohepatitis, or NASH with liver fibrosis. Pliant is initiating
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:
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Investor and Media Contact:
Christopher KeenanVice President, Investor Relations and
Corporate CommunicationsPliant Therapeutics,
Inc.ir@pliantrx.com
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