Bridge Biotherapeutics announced it has received notice from the U.S. Food and Drug Administration (FDA) that it may proceed with a Phase 2 clinical study of BBT-877, an autotaxin inhibitor to treat patients with idiopathic pulmonary fibrosis (IPF). (US IND Number: IND 140199, NCT identifier: NCT05483907). Following a Type C meeting for proceeding development of BBT-877 with the FDA in June 2021, the company submitted non-clinical data inclusive of in vivo comet assays with transmission electron microscopy (TEM) evaluation, and the protocol to fully support the safety of clinical studies in IPF patient participants.

The U.S. FDA finally approved the final protocol, and confirmed the advancement of Phase 2 clinical study of BBT-877.