South Korean biotech company Bridge Biotherapeutics Inc and its JLABS TMC (Houston, Texas) company announced on Friday the successful submission of an Investigational New Drug (IND) application for BBT-877 drug candidate for Idiopathic Pulmonary Fibrosis (IPF) with the US Food and Drug Administration (FDA).

Idiopathic Pulmonary Fibrosis (IPF) is reportedly a progressive, irreversible and fatal lung disease.

BBT-877, a potent and selective Autotaxin (ENPP) inhibitor is being developed potentially for the treatment of various fibrotic diseases including idiopathic pulmonary fibrosis (IPF) and non-alcoholic steatohepatitis (NASH). BBT-877 is reportedly the second molecule from Bridge Biotherapeutics.

In January 2019, Bridge Biotherapeutics plans to start a Phase I study of BBT-877 to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug candidate in healthy volunteers in the US. The planned study will be performed in two phases, a Single Ascending Dose (SAD) phase with five cohorts and a Multi Ascending Dose (MAD) phase with three cohorts. The estimated primary completion date is currently expected in late 2019.

Additionally, Bridge Biotherapeutics presented the results of the preclinical study on BBT-877 at the IPF Summit in August 2018, 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.

Concurrently, Bridge is developing BBT-401, the first anti-Pellino-1 compound for the ulcerative colitis and aims to initiate the Phase II study in the US within this year.