Bridge Biotherapeutics Announces FDA Orphan Drug Designation for BBT-877 in Idiopathic Pulmonary Fibrosis (IPF)

The U.S. FDA grants an orphan drug designation to BBT-877 in IPF

The first-in-human clinical study is set to begin next month

SEONGNAM,South Korea,Jan. 16,2019 -- 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 U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to BBT-877,a drug candidate under development for Idiopathic Pulmonary Fibrosis (IPF) treatment.

BBT-877,a potent best-in-class Autotaxin (ATX) inhibitor deregulates ATX,the enzyme found to be engaging in inflammation and fibrosis by generating the lipid signaling molecule. The early-stage compound of BBT-877 had been originally discovered by LegoChem Biosciences and has been under the development process by the lead of Bridge Biotherapeutics since the company acquired the worldwide exclusive right for further developments in 2017.

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.

Bridge Biotherapeutics will commence a Phase 1 study of BBT-877 in the U.S. next month to assess the safety,tolerability,pharmacokinetics and pharmacodynamics of the drug candidate in healthy volunteers. The planned study will be performed in two phases,a Single Ascending Dose (SAD) phase with 5 cohorts and a Multi Ascending Dose (MAD) phase with 3 cohorts. The estimated primary completion date is currently expected in late 2019.

"Our team has been highly encouraged by the FDA orphan drug designation,which reflects huge unmet medical needs in IPF treatment worldwide," and "We will keep focused on the accelerated development process of BBT-877 to achieve significant milestones in the near term," commented Dr. Gwang-hee Lee,the Head of Translational Research at Bridge Biotherapeutics.

The orphan drug designation (ODD) by the U.S. FDA is granted to promote the development of drugs intended to treat rare diseases or disorders affecting fewer than 200,000 patients in the U.S.,or more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug. The orphan drug designation qualifies the drugs for benefits across the development process supporting advancements.

BBT-877 is the second molecule from Bridge Biotherapeutics with the U.S. FDA clearances of IND for proceeding clinical studies. The company is also developing BBT-401,the first anti-Pellino-1 compound for ulcerative colitis and expects the first dosing in the selective patient group in February,under the Phase 2 study.

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.

4. FDA Orphan Drug Designation Program

The Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment,diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.,or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

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