Biotech company Bridge Biotherapeutics Inc revealed on Wednesday the receipt of the US Food and Drug Administration's (FDA) orphan drug designation (ODD) to promote the development of the drug candidate BBT-877 for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a progressive, irreversible and fatal lung disease.

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.

According to the company, BBT-877 is 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. BBT-877 is the second molecule under the US FDA's clearances of IND for proceeding clinical studies.

In August 2018, the company gave a presentation of 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.

Additionally, the company will launch a Phase 1 study of BBT-877 in the US 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 five cohorts and a Multi Ascending Dose (MAD) phase with three cohorts. The estimated primary completion date is currently expected in late 2019.