Pliant Therapeutics Announces Presentations at the European Respiratory Society International Congress 2023
September 11 2023 - 8:00AM
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage
biotechnology company focused on discovering and developing novel
therapeutics for the treatment of fibrosis, today announced
presentations made at the European Respiratory Society (ERS)
International Congress 2023 taking place from September 9, 2023 to
September 13, 2023.
“We are pleased to be sharing non-clinical and
clinical data at this important congress, including, for the first
time at a scientific session, the final results from our
INTEGRIS-IPF Phase 2a trial. Data from this trial support the
late-stage development of bexotegrast as part of the BEACON-IPF
trial and highlight our commitment to developing potential
treatments for fibrotic diseases,” said Éric Lefebvre, M.D., Chief
Medical Officer at Pliant Therapeutics.
Safety, tolerability and antifibrotic
activity of bexotegrast: Phase 2a INTEGRIS-IPF Study
(NCT04396756)
Findings from the 24-week analysis of our recently
completed INTEGRIS-IPF Phase 2a trial of bexotegrast in patients
with idiopathic pulmonary fibrosis (IPF) were presented in
late-breaking oral and e-poster forms. Results showed that
bexotegrast at 320 mg was well tolerated for up to 40 weeks of
treatment with no discontinuations due to treatment-emergent
adverse events occurring from Week 12 to Week 40. Additionally,
over 24 weeks, a durable treatment effect on forced vital capacity
(FVC) was observed in a population predominantly using IPF
background therapies (nintedanib or pirfenidone). Quantitative lung
fibrosis (QLF) imaging continued to demonstrate the antifibrotic
mechanism of bexotegrast: at Week 24, the proportion of bexotegrast
320 mg-treated participants who experienced a stabilization or
improvement of fibrosis was twice as high as those in the placebo
group.
Dual αVβ6/αVβ1 integrin inhibitor
bexotegrast reduces fibrogenesis in pathological cell populations
present in the fibrotic human lung
Results from a single nuclei RNASeq analysis of
bexotegrast-treated precision-cut lung slices prepared from
fibrotic human tissue were presented in oral and poster forms.
Results showed that bexotegrast treatment reduced the expression of
pro-fibrogenic genes and pathways in pro-fibrotic (CTHRC1+)
fibroblasts, as well as in aberrant basaloid cells known to express
integrin αVβ6.
Circulating ITGB6 levels are elevated in
patients with IPF and reduced following lung
transplant
Results from a study comparing serum concentrations
of integrin β6 in patients with IPF (pre/post-transplant) and
healthy subjects was presented in poster form. Results showed that
serum concentrations of integrin β6 were significantly elevated in
patients with IPF compared to healthy controls, and that levels
were significantly reduced in patients with IPF following lung
transplant. Further analysis of circulating integrin β6 in clinical
trials may help to better characterize its utility as an early
biomarker of response to anti-fibrotic therapy.
Posters presented at the 2023 ERS International
Congress are also available on Pliant’s website under the
Publications section at https://pliantrx.com/publications.
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, PLN-101325 and
PLN-101095; bexotegrast’s potential to become a treatment for IPF
or PSC; the anticipated timing of data and progress from our
clinical studies; discussions with regulatory authorities; the
sufficiency of our cash runway to fund operations into the second
half of 2026. 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,
including lingering effects 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, 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 three months 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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