Bridge Biotherapeutics Completes Enrollment in Phase 2a Study of BBT-877 for Idiopathic Pulmonary Fibrosis

Bridge Biotherapeutics, a biotech company based in South Korea, has announced the completion of patient enrollment in its Phase 2 clinical trial for BBT-877, a novel autotaxin (ATX) inhibitor aimed at treating idiopathic pulmonary fibrosis (IPF). This clinical-stage company focuses on developing new treatments for fibrosis and cancer.

The Phase 2 study, known as NCT05483907, is a multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate BBT-877's effectiveness, safety, and tolerability in IPF patients. The study includes patients who are either on approved anti-fibrotic therapies such as pirfenidone or nintedanib or not. The main goal is to assess the reduction in forced vital capacity (FVC) in patients treated with BBT-877 compared to those receiving a placebo after 24 weeks of treatment. Secondary objectives include evaluating the drug's safety, pharmacokinetics (PK), lung function through diffusing capacity of the lung for carbon monoxide (DLCO), and overall functional exercise capacity.

A total of 120 participants were enrolled in the study from around 50 clinical trial sites across the U.S., South Korea, Australia, Poland, and Israel. These participants were randomly assigned to either the experimental group, receiving 200mg of BBT-877 twice daily, or a placebo group.

James Lee, the founder and CEO of Bridge Biotherapeutics, emphasized the importance of completing the patient enrollment phase, marking it as a significant milestone in developing innovative treatments for IPF patients. Lee also mentioned the company's ongoing efforts to seek global partnerships to advance the drug into the next phase of the study, aiming to affirm its efficacy and safety in a broader patient population.

The company plans to announce topline results from this study in the first half of 2025. Concurrently, Bridge Biotherapeutics is pursuing a global partnership strategy to prepare for subsequent phases of development, which will involve more extensive patient studies to further verify BBT-877's effectiveness and safety.

BBT-877 has shown promise as an experimental ATX inhibitor, demonstrating up to 90% inhibition of lysophosphatidic acid (LPA) production in earlier human studies. LPA is a lipid that binds to cell receptors, initiating various physiological processes, such as neovascularization, sclerosis, tumor growth, and metastasis. These activities contribute to the development of fibrotic diseases like IPF. The National Institutes of Health (NIH) in the U.S. estimates that over 30,000 new cases of IPF are diagnosed annually in the country, with as many as 3 million people affected globally.

Bridge Biotherapeutics Inc., established in 2015, operates in both South Korea and the U.S. The company is publicly traded and focuses on discovering and developing novel therapeutics to address unmet medical needs, particularly in fibrotic diseases and cancers. Apart from BBT-877, the company is also working on BBT-207, a targeted cancer therapy for non-small cell lung cancer (NSCLC) with EGFR C797S mutations.

BBT-877 is an oral autotaxin enzyme inhibitor, currently in development for treating idiopathic pulmonary fibrosis (IPF). In Phase 1 trials, BBT-877 demonstrated significant inhibition of the enzyme lysophosphatidic acid (LPA) in multiple dose cohorts. Results from the Phase 2a study are anticipated in the first half of 2025.

Autotaxin (ATX) is a crucial enzyme discovered in the early 1990s that generates the lipid-signaling molecule LPA. This enzyme's conversion of lysophosphatidylcholine (LPC) into LPA triggers signaling that promotes cell proliferation, migration, cytokine and chemokine secretion, and reduced cell apoptosis. Given its role in inflammation and fibrosis, autotaxin is a promising target for drug development.

Idiopathic pulmonary fibrosis (IPF) is a rare, severe lung disease affecting around 3 million people worldwide. The progression of IPF is unpredictable, leading to a gradual and irreversible decline in lung function.

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