Bridge Biotherapeutics will evaluate the efficacy, safety, and tolerability of BBT-877, an experimental autotaxin inhibitor, in patients with idiopathic pulmonary fibrosis (IPF) in a phase 2, randomized, double-blind, placebo-controlled, 24-week clinical trial.

“The phase 2 trial of BBT-877 is part of our unique franchise approach to treating idiopathic pulmonary fibrosis,” said James Lee, founder and CEO of Bridge Biotherapeutics. “BBT-877 is the most advanced asset in our IPF program, which includes BBT-301 and BBT-209. Bridge remains focused on developing novel treatments for IPF through a variety of modalities.”

The study will enroll approximately 120 patients (40 years and older), with or without IPF-approved background therapies (pirfenidone or nintedanib), who will be taking 200 mg twice daily of either BBT-877 or a placebo.


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The primary endpoint of the study is the evaluation of BBT-877 efficacy in IPF patients as measured by the change from baseline in forced vital capacity at week 24 of treatment. In addition, the study will include a 4-week follow-up period.

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The study will extend to approximately 50 sites in North America, Europe, and the Asia Pacific region in the next year.

BBT-877 is a potent inhibitor of autotaxin, an enzyme involved in the synthesis of lysophosphatidic acid (LPA). LPA signaling has been implicated in neovascularization, sclerosis, tumorigenesis, and tumor metastasis, leading to the development of various fibrotic diseases, including IPF. Data from a phase 1 study showed that BBT-887 was able to inhibit LPA by up to 90% in multiple-ascending dose cohorts.

Reference

Bridge Biotherapeutics initiates phase 2 clinical trial of BBT-877 in patients with idiopathic pulmonary fibrosis. News release. Bridge Biotherapeutics, Inc.; November 7, 2022.