
Bridge Biotherapeutics, a clinical-stage biotech company based in South Korea developing novel drugs for fibrosis, cancer and inflammation, has dosed the first patient in its phase 2a clinical study to evaluate the efficacy, safety and tolerability of BBT-877 in patients with idiopathic pulmonary fibrosis (IPF).
In the phase 1 study in 2019, BBT-877, a potent autotaxin (ATX) inhibitor, demonstrated its ability to inhibit lysophosphatidic acid (LPA) production by as much as 90%. 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, multicenter, randomized, double-blind, placebo-controlled study will use 200 mg, 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 activated for the study. The company plans to announce topline data in the second half of 2023.
"The first patient dosing of BBT-877 marks an important milestone in our efforts to develop innovative treatments for patients suffering from idiopathic pulmonary fibrosis," said James Lee, founder and CEO of Bridge Biotherapeutics. "We are dedicated to the advancement of this novel drug candidate, which we believe has the potential to make a meaningful impact in the lives of IPF patients and their families."