13 April 2023 | Thursday | News
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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 percent. 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 (NCT05483907) 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 activated for the study. The Company maintains its guidance that it expects to announce topline data in the second half of 2023.
James Lee, founder and CEO of Bridge Biotherapeutics, said: "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. 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."
The National Institutes of Health in the U.S. estimates that more than 30,000 new cases of IPF are diagnosed in the U.S. alone each year, and as many as 3 million patients are affected worldwide.