Bridge Biotherapeutics Initiates Phase 2 Clinical Trial of BBT-877 in Patients with Idiopathic Pulmonary Fibrosis

• The Phase 2 study will evaluate the efficacy, safety, and tolerability of BBT-877 in idiopathic pulmonary fibrosis patients
• Data from the Phase 1 clinical study demonstrated LPA inhibition of up to 90 percent, which is expected to translate to treatment efficacy in IPF patients
• Phase 2 clinical study is expected to enroll up to 120 patients across North America, Europe and the Asia Pacific regions

SEONGNAM, South Korea, Nov. 7, 2022 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for cancer, fibrosis and inflammation, announced the initiation of a Phase 2a clinical trial evaluating the efficacy, safety, and tolerability of BBT-877 in patients with idiopathic pulmonary fibrosis (IPF).

BBT-877, a potent autotaxin (ATX) inhibitor, demonstrated its ability to inhibit lysophosphatidic acid (LPA) production by as much as 90 percent through a Phase 1 study in 2019. 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 Phase 2, multi-center, randomized, double-blind, placebo-controlled study will utilize 200mg, twice daily (BID) regimen of BBT-877 or a placebo. The study will enroll approximately 120 patients who have or have not been treated with current standard treatments, which include pirfenidone or nintedanib. Approximately 50 sites in North America, Europe, and the Asia Pacific region are planned to be selected by next year.

The primary endpoint is the evaluation of the efficacy of BBT-877 in IPF patients through the measurement of the reduction in forced vital capacity (FVC) in patient treated with BBT-877 compared to those treated with placebo at week 24 of treatment. Forced vital capacity is used to measure a lung function and measures the total amount of air a patient is able to exhale.

"The Phase 2 trial of BBT-877 is part of our unique franchise approach to treating idiopathic pulmonary fibrosis," said James Lee, founder and CEO of Bridge Biotherapeutics. "BBT-877 is the most advanced asset in our IPF program, which includes BBT-301 and BBT-209. Bridge remains focused on developing novel treatments for IPF through a variety of modalities."

Further information about the clinical trial is available at www.clinicaltrials.gov/show/NCT05483907.

About Bridge Biotherapeutics, Inc.

Bridge Biotherapeutics Inc., based in the Republic of Korea, the U.S., and China, 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 ulcerative colitis, fibrotic diseases, and cancers. The company is developing BBT-401, a first-in-class Pellino-1 inhibitor for the treatment of ulcerative colitis, BBT-877, a novel autotaxin inhibitor for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF), and BBT-176, a potent targeted cancer therapy for non-small cell lung cancer (NSCLC) with C797S triple EGFR mutations. Learn more at https://www.bridgebiorx.com/ .

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. BBT-877, an experimental autotaxin inhibitor, demonstrated LPA inhibition of up to 90 percent in multiple-ascending dose cohorts of the Phase 1 study.

About idiopathic pulmonary fibrosis (IPF)

IPF is a rare, debilitating and fatal lung disease which affects approximately 3 million people worldwide. Progression of IPF is variable and unpredictable. Over time, the lung function of an IPF patient gradually and irreversibly declines.

SOURCE Bridge Biotherapeutics, Inc.