The US Food and Drug Administration (FDA) has granted authorization to Bridge Biotherapeutics to carry out a phase 2 trial on BBT-877, an autotaxin inhibitor, for patients with idiopathic pulmonary fibrosis (IPF).
The authorization, announced by news release, followed a Type C meeting with the FDA in June 2021 for the proceeding development of BBT-877, during which the company submitted nonclinical comet assay data and the trial protocol.
Bridge Biotherapeutics will launch the 24-week randomized, double-blind, placebo-controlled clinical trial later in 2022 in North America, Asia, and Europe. It will include approximately 50 clinical sites.
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Patients with IPF will take 100 mg capsules, or a placebo, orally twice a day for 180 days as monotherapy or adjunct therapy. The primary outcome measure will be the change from baseline in forced vital capacity at week 24 compared to placebo. Results will be stratified based on the presence or absence of adjunct therapy.
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Autotaxin is a novel extracellular enzyme containing approximately 900 amino acids that has a pathogenic role in inflammation and fibrosis in conditions such as IPF. It stimulates lysophosphatidic acid (LPA) signaling, resulting in cell proliferation, migration, cytokine and chemokine secretion, and reduced apoptosis, making it an attractive target for autotaxin inhibitors such as BBT-877.
In multiple-ascending dose cohorts of its phase 1 study, BBT-877 demonstrated good tolerability and LPA inhibition of up to 90%.
Reference
Bridge Biotherapeutics receives FDA authorization to proceed with phase 2 study of BBT-877. News release. Bridge Biotherapeutics, Inc; August 15, 2022.
