South Korean biotech company Bridge Biotherapeutics Inc disclosed on Monday that it has submitted its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to launch a phase I study of the potent best-in-class drug candidate BBT-877 for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a progressive, an irreversible and fatal lung disease.

In August 2018, the company 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.

In conjunction, the company plans to start a Single Ascending Dose (SAD) study in the US in January 2019 if IND is well cleared in December. In the Phase I study with healthy volunteers, the safety and tolerability of BBT-877 will be the primary endpoints of the study.

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

Autotaxin (ATX) is a protein of approximately 900 amino acids 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. Autotaxin has been found to be engaged in inflammation and fibrosis and it emerges as one of attractive drug targets, concluded the company.