SEONGNAM, South Korea, July 29,
2024 /PRNewswire/ -- Bridge Biotherapeutics
(KQ288330), a clinical-stage biotech company based in South Korea developing novel drugs for
fibrosis and cancer, today announced that patient participant
enrollment has been completed in the Phase 2 clinical study of
BBT-877, a novel autotoxin (ATX) inhibitor for the treatment of
idiopathic pulmonary fibrosis (IPF).
The Phase 2, multi-center, randomized, double-blind,
placebo-controlled study (NCT05483907) aims to evaluate the
efficacy, safety, and tolerability of BBT-877 in patients with IPF,
with or without anti-fibrotic (AF) approved background therapies
(pirfenidone or nintedanib). The primary objective is the
evaluation of the efficacy of BBT-877 in IPF patients by measuring
the reduction in forced vital capacity (FVC) in patients treated
with BBT-877 compared to those treated with a placebo at week 24 of
treatment. Secondary objectives of the study include the evaluation
of drug safety, pharmacokinetics (PK), diffusing capacity of lung
for carbon monoxide (DLCO), and functional exercise capacity in all
patients.
A total of 120 patient participants were enrolled from
approximately 50 clinical trial sites located in the U.S.,
South Korea, Australia, Poland, and Israel, representing diversity of ethnicity
and race. Patients were randomized to either the experimental drug
arm or the placebo arm, following a 200mg, twice daily (BID)
regimen of BBT-877 or a placebo.
James Lee, founder and CEO of
Bridge Biotherapeutics, said: "The completion of enrollment in the
phase 2a clinical study of BBT-877 marks an important milestone in
our efforts to develop innovative treatments for patients suffering
from IPF. Closely looking for business alliance opportunities in
the global pharmaceutical industry, we will remain dedicated to
advancing this novel drug candidate, which we believe has the
potential to make clinically meaningful outcomes in IPF
patients."
The Company expects topline data from this study to be announced
in the first half of 2025. In parallel with advancing the study,
the company pursues a global partnership to prepare for the next
phase of the study to further validate the efficacy and safety of
BBT-877 in a larger number of patients around the world.
BBT-877, an experimental Autotaxin (ATX) inhibitor, demonstrated
its ability to inhibit lysophosphatidic acid (LPA) production by up
to 90 percent in the first-in-human study. LPA is known to
bind to cell receptors and induce various physiological
activities, such as neovascularization, sclerosis, tumorigenesis,
and tumor metastasis, leading to the development of various
fibrotic diseases, including IPF. The National Institutes of
Health (NIH) in the U.S. estimates that more than 30,000 new cases
of IPF are diagnosed in the U.S. alone each year, and as many as 3
million patients are affected worldwide.
About Bridge Biotherapeutics, Inc.
Bridge Biotherapeutics Inc., based in the Republic of Korea and
the U.S., is a publicly traded, clinical-stage biotech company
founded in 2015. Bridge Biotherapeutics is engaged in the discovery
and development of novel therapeutics, focusing on therapeutic
areas with high unmet needs, including fibrotic diseases and
cancers. The company is developing BBT-877, a novel autotaxin
inhibitor for the treatment of fibrotic diseases including
idiopathic pulmonary fibrosis (IPF), and BBT-207, a potent targeted
cancer therapy for non-small cell lung cancer (NSCLC) with EGFR
C797S mutations. Learn more at https://www.bridgebiorx.com/en/.
About BBT-877
BBT-877 is an orally administered autotaxin enzyme inhibitor
which is under development as a treatment for idiopathic pulmonary
fibrosis (IPF). During the Phase 1 Clinical Study, the experimental
autotaxin inhibitor demonstrated lysophosphatidic acid (LPA)
inhibition of up to 90 percent in multiple-ascending dose cohorts.
The topline data of the Phase 2a Clinical Study are expected to be
announced in the first half of 2025.
About Autotaxin
Autotaxin (ATX), a protein of approximately 900 amino acids
discovered in the early 1990s, is an important enzyme for
generating the lipid-signaling molecule, lysophosphatidic acid
(LPA). Autotaxin's lysophospholipase D activity converts
lysophosphatidylcholine (LPC) into LPA, which engages in signaling
via LPA receptors. LPA signaling results in cell proliferation,
migration, secretion of cytokines and chemokines, and reduction of
cell apoptosis. Ultimately, autotaxin has a pathogenic role in
processes of inflammation and fibrosis, making it an attractive
drug target.
About idiopathic pulmonary fibrosis (IPF)
IPF is a rare, debilitating, and fatal lung disease that affects
approximately 3 million people worldwide. The progression of IPF is
variable and unpredictable. Over time, the lung function of an IPF
patient gradually and irreversibly declines.
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SOURCE Bridge Biotherapeutics, Inc.