Bridge Biotherapeutics filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to start a Phase 1 trial of its idiopathic pulmonary fibrosis (IPF) treatment candidate BBT-877 in January.
BBT-877 is an inhibitor of the enzyme autotaxin (ATX). This enzyme is relevant in the generation of the lipid (fat) cellular signaling molecule lysophosphatidic acid (LPA). Prior studies have shown that LPA increases lung, kidney, and liver fibrosis (scarring) through cell proliferation and migration. It also releases inflammatory molecules and decreases apoptosis — “programmed” cell death, as opposed to cell death caused by injury.
“We are proud of the IND submission for BBT-877, which has shown a strong potential to be developed as the best-in-class autotaxin inhibitor for IPF treatment,” Gwang-hee Lee, Bridge’s head of translational research, said in a press release.
Bridge expects to begin the Phase 1 Single Ascending Dose study in healthy volunteers in January, provided that the FDA clears the application. The trial’s primary goals will be the safety and tolerability of BBT-877.
“Our team will do our best to develop the best-in-class drug to address huge unmet medical needs in IPF,” Lee said.
In August, the South Korea-based company presented preclinical data of BBT-877 at the 2nd Annual IPF Summit, in San Francisco. The results showed that in a mouse model of IPF, BBT-877 was superior to other compounds in lessening lung fibrosis, as evaluated by the Ashcroft score (a measure of IPF severity) and the deposition of collagen — a critical event in the development of fibrosis.
Besides IPF, BBT-877 is intended for the treatment of other fibrotic disease such as non-alcoholic steatohepatitis.
The therapy was originally developed by LegoChem Biosciences and was licensed to Bridge in 2017.
“We appreciate Bridge Biotherapeutics team’s effort to develop this compound in such tremendous energy and speed,” said Yong Zu Kim, LegoChem’s CEO and president. “This progress exemplifies a good collaboration between a discovery-focused biotech [LegoChem] and a development-focused biotech [Bridge] in Korea’s vibrant biotech ecosystem.”
Besides BBT-877, Bridge is also developing BBT-401, an inhibitor of the protein Pellino-1, for the treatment of ulcerative colitis, a type of inflammatory bowel disease. Pellino-1 is implicated in inflammation. The company aims to start a Phase 2 trial with BBT-401 in the U.S. soon.