Bridge Biotherapeutics Files Investigational New Drug Application for BBT-877, an Autotaxin Inhibitor for Idiopathic Pulmonary Fibrosis

The first-in-human study will be initiated early next year

Orphan Drug Designation application was filed for IPF

SEONGNAM,South Korea,Nov. 18,2018 -- Bridge Biotherapeutics Inc.,a clinical stage biotech company headquartered in Seongnam,South Korea and a tenant company of JLABS@TMC in Houston,Texas,announced that the company filed an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate phase I study of BBT-877,a potent best-in-class drug candidate for Idiopathic Pulmonary Fibrosis (IPF) treatment.

BBT-877,an Autotaxin inhibitor,has been originally discovered by LegoChem Biosciences,a publicly traded Korean biotech,and was licensed to Bridge Biotherapeutics in 2017 for the worldwide exclusive right for further development.

In August 2018,Bridge Biotherapeutics presented the results of the preclinical study on BBT-877 at the IPF Summit,attracting pulmonologists' interest on the efficacy and safety of the drug candidate. The data has demonstrated the best-in-class opportunity in comparison to a current development pipeline compound.

"We are proud of the IND submission for BBT-877,which has shown a strong potential to be developed as the best-in-class Autotaxin inhibitor for IPF treatment and we expect the first human dosing in healthy volunteers will be initiated in January 2019,if the FDA clears the application. Our team will do our best to develop the best-in-class drug to address huge unmet medical needs in IPF," stated Dr. Gwang-hee Lee,the Head of Translational Research at Bridge Biotherapeutics.

In addition,Yong Zu Kim,the CEO and President of LegoChem Biosciences mentioned,"We appreciate Bridge Biotherapeutics team's effort to develop this compound in such tremendous energy and speed since the licensing agreement in 2017 and this progress exemplifies a good collaboration between a discovery-focused biotech and a development-focused biotech in Korea's vibrant biotech ecosystem."

The company expects that it will be able to initiate a Single Ascending Dose (SAD) study in the U.S. in January 2019 if IND is well cleared in December. In the Phase I study with healthy volunteers,safety and tolerability of BBT-877 will be the primary endpoints of the study.

Bridge Biotherapeutics is also developing BBT-401,the first anti-Pellino-1 compound for the ulcerative colitis and aims to initiate the phase II study in the U.S. within this year.

For more information

1. Bridge Biotherapeutics,Inc.

Bridge Biotherapeutics is a virtually-operated,venture-backed clinical stage biotech engaged in the development of novel therapeutics in the therapeutic areas of high unmet needs such as ulcerative colitis,fibrotic diseases and cancers. Following its first compound BBT-401,BBT-877,a potent and selective Autotaxin (ENPP) inhibitor is being developed potentially for the treatment of various fibrotic diseases such as idiopathic pulmonary fibrosis (IPF) and non-alcoholic steatohepatitis (NASH). Bridge Biotherapeutics is a JLABS tenant company at JLABS@TMC,Houston,TX.

2. Autotaxin

Autotaxin (ATX) is a protein of approximately 900 amino acids discovered in the early 1990s,and an enzyme important for generating the lipid signaling molecule,lysophosphatidic acid (LPA). Autotaxin has lysophospholipase D activity that converts lysophosphatidylcholine (LPC) into LPA. LPA,the bioactive lipid catalyzed by Autotaxin,engages in signaling via LPA receptors and the LPA signaling results in cell proliferation,migration,secretion of cytokine and chemokine and reduction of cell apoptosis. Pathologically,Autotaxin has been found to be engaged in inflammation and fibrosis and it emerges as one of attractive drug targets.

3. Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic Pulmonary Fibrosis (IPF) is a progressive,irreversible and fatal lung disease. A number of investigational drugs are being developed while only two therapeutics,pirfenidone,and nintedanib,were approved by the U.S. FDA.

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