SEONGNAM, South Korea and CAMBRIDGE, Mass., April 13, 2023 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a clinical-stage biotech company based in South Korea developing novel drugs for fibrosis, cancer, and inflammation, announced it has dosed the first patient in its Phase 2a clinical study to evaluate the efficacy, safety, and tolerability of BBT-877 in patients with idiopathic pulmonary fibrosis (IPF).

In the Phase 1 study in 2019, BBT-877, a potent autotaxin (ATX) inhibitor, demonstrated its ability to inhibit lysophosphatidic acid (LPA) production by as much as 90 percent. 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 (NCT05483907) 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 activated for the study. The Company maintains its guidance that it expects to announce topline data in the second half of 2023.

James Lee, founder and CEO of Bridge Biotherapeutics, said: "The first patient dosing of BBT-877 marks an important milestone in our efforts to develop innovative treatments for patients suffering from idiopathic pulmonary fibrosis. We are dedicated to the advancement of this novel drug candidate, which we believe has the potential to make a meaningful impact in the lives of IPF patients and their families."

The National Institutes of Health 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, 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, and has several drug candidates in preclinical development. 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 various fibrotic diseases such as idiopathic pulmonary fibrosis (IPF). During the Phase 1 Clinical trial, 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 Trial is expected to be announced in the second half of 2023.

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 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.