Bridge Biotherapeutics announced the initiation of a Phase 2a clinical trial evaluating the efficacy, safety, and tolerability of BBT-877 in patients with idiopathic pulmonary fibrosis (IPF). BBT-877, a potent autotaxin (ATX) inhibitor, demonstrated its ability to inhibit lysophosphatidic acid (LPA) production by as much as 90% through a Phase 1 study in 2019. LPA is known to bind to cell receptors and induce various physiological activities, such as neovascularization, sclerosis, tumorigenesis and tumor metastasis, leading to the development of various fibrotic diseases, including IPF.

The Phase 2, multi-center, randomized, double-blind, placebo-controlled study will utilize 200mg, twice daily (BID) regimen of BBT-877 or a placebo. The study will enroll approximately 120 patients who have or have not been treated with current standard treatments, which include pirfenidone or nintedanib. Approximately 50 sites in North America, Europe, and the Asia Pacific region are planned to be selected by next year.

The primary endpoint is the evaluation of the efficacy of BBT-877 in IPF patients through the measurement of the reduction in forced vital capacity (FVC) in patient treated with BBT-877 compared to those treated with placebo at week 24 of treatment. Forced vital capacity is used to measure a lung function and measures the total amount of air a patient is able to exhale.