Pliant Therapeutics Announces Initiation of BEACON-IPF, a Phase 2b Clinical Trial of Bexotegrast in Idiopathic Pulmonary Fibrosis
2023年8月9日 - 9:00PM
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage
biotechnology company focused on discovering and developing novel
therapeutics for the treatment of fibrosis, today announced the
initiation of BEACON-IPF, a Phase 2b clinical trial of bexotegrast
in patients with idiopathic pulmonary fibrosis (IPF). Bexotegrast
is an oral, small molecule, dual-selective inhibitor of αvβ6 and
αvβ1 integrins in clinical development for the treatment of IPF and
primary sclerosing cholangitis (PSC).
“IPF remains an area of great unmet need. With the start of
BEACON-IPF, we are achieving an important company milestone and
taking a step forward to potentially bringing this novel drug
candidate to patients,” said Éric Lefebvre, M.D., Chief Medical
Officer at Pliant Therapeutics. “BEACON-IPF follows the positive
results from our Phase 2a INTEGRIS-IPF trial demonstrating
bexotegrast was well tolerated and demonstrated encouraging
preliminary patient benefits for those both on and off current
background therapies. We look forward to advancing this trial to
further our understanding of bexotegrast as a potential therapy in
the treatment of IPF.”
BEACON-IPF is a 52-week, multinational, randomized,
dose-ranging, double-blind, placebo-controlled Phase 2b trial
evaluating bexotegrast at doses of 160 mg or 320 mg. The trial is
planning to enroll approximately 270 patients with IPF at sites
globally. The primary endpoint of BEACON-IPF is the assessment of
the change from baseline in absolute forced vital capacity (FVC) mL
at Week 52. Secondary endpoints include the measurement of time to
disease progression (≥10% absolute decline from baseline in FVC
precent predicted (FVCpp), respiratory-related hospitalization, or
all-cause mortality), change from baseline in absolute FVC (mL) on
or not on background therapies, change from baseline in patient
reported measurements of symptoms, well-being at Week 52 and safety
and tolerability.
About Idiopathic Pulmonary Fibrosis
IPF is a chronic, progressive, fibrosing lung disease of unknown
cause with few treatment options and a poor prognosis. Patients
experience debilitating symptoms, including shortness of breath and
difficulty performing daily activities, such as walking and
talking. Currently, there is no pharmacological cure for IPF, with
neither of the approved two therapies demonstrating an ability to
stop the progression of IPF. Therefore, there is a high unmet need
for new therapeutic options to address the symptoms and modify the
disease progression of this grievous illness.
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
has initiated BEACON-IPF, a Phase 2b trial in IPF. Pliant has also
developed PLN-1474, a small molecule, selective inhibitor of the
αvß1 integrin 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:
Twitter, LinkedIn, Facebook and YouTube.
Forward-Looking StatementsStatements 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.
Investor and Media Contact:
Christopher KeenanVice President, Investor Relations and
Corporate CommunicationsPliant Therapeutics,
Inc.ir@pliantrx.com
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