Postive Interim Results from Ongoing Phase 1 Trial Presented at ATS 2019
SEONGNAM, South Korea and DALLAS, May 20, 2019 /PRNewswire/ — Bridge Biotherapeutics Inc., a clinical-stage biotech company developing novel therapeutics for areas with high unmet medical needs, announced that the company presented interim data from a Phase I clinical study on BBT-877, a drug candidate for treatment of idiopathic pulmonary fibrosis (IPF), at the American Thoracic Society International Conference (ATS 2019) held in Dallas, Texas from May 17-22.
Interim pharmacokinetic and safety results from the randomized, double-blind, placebo-controlled, Phase I study were included in a poster "BBT-877, a potent Autotaxin Inhibitor in Clinical Development to Treat Idiopathic Pulmonary Fibrosis" presented on May 19, during the Pathophysiology in Diffuse Parenchymal Lung Diseases poster session.
In the single-ascending dose (SAD) portion of the study, plasma concentrations of BBT-877 increased with dose in a dose-proportional manner. All doses demonstrated safety and tolerability, with only mild adverse events (AEs) and no serious AEs. Furthermore, there were no clinically related findings in safety assessments of the study, such as electrocardiogram, vital sign, laboratory biochemical/hematological profile, and urinalysis results.
"We remain highly focused on the clinical development of BBT-877," said Gwang-hee Lee, PhD, Vice President, Head of Translational Research at Bridge Biotherapeutics. "BBT-877 has shown potential as a best-in-class ATX inhibitor for treatment of IPF with favorable results in the first-in-human, clinical study. These findings reinforce our continued collaborations with world-class pulmonologists specializing in IPF."
The Phase I study of BBT-877 (ClinicalTrials.gov Identifier: NCT03830125) is expected to be finalized by August 2019, and a multinational Phase II study is planned to be conducted in the U.S., Canada, Australia, and multiple countries in Europe and Asia.
Preclinical research of BBT-877 has demonstrated its potency and in vivo efficacy as an ATX inhibitor and best-in-class potential. These interim clinical data contribute to the BBT-877 safety and tolerability demonstrated to date and support the continued development of BBT-877 for treatment of IPF.
The original file of the poster presented at the ATS 2019 is available at http://bridgebiorx.com/upload/pdf/71eba4a326161df0da5f6abf636f2a58.pdf.
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About Bridge Biotherapeutics
Bridge Biotherapeutics is a clinical stage biotech company engaged in the discovery and development of novel therapeutics, focusing on therapeutic areas with high unmet needs, such as ulcerative colitis, fibrotic diseases, and cancers. Following its first compound BBT-401, a drug candidate for treatment of ulcerative colitis, Bridge Biotherapeutics is developing BBT-877 for treatment of various fibrotic diseases, including idiopathic pulmonary fibrosis (IPF) and non-alcoholic steatohepatitis (NASH). BBT-176, a potent targeted cancer therapy for non–small cell lung cancer (NSCLC), and BBT-931, an immune-oncology therapy, are also in development. Bridge Biotherapeutics is a JLABS tenant company at JLABS@TMC, Houston, TX.
Autotaxin (ATX) is a protein of approximately 900 amino acids discovered in the early 1990s and is an important enzyme for generating the lipid-signaling molecule, lysophosphatidic acid (LPA). Autotaxin has lysophospholipase D activity that converts lysophosphatidylcholine (LPC) into LPA, which engages in signaling via LPA receptors. LPA signaling results in cell proliferation, migration, secretion of cytokines and chemokines, and reduction of cell apoptosis. Ultimately, autotaxin has a pathogenic role in processes of inflammation and fibrosis, making it an attractive drug target.
About idiopathic pulmonary fibrosis (IPF)
Idiopathic pulmonary fibrosis (IPF) is a progressive and irreversible, fatal lung disease characterized by difficulty breathing, cough, and impaired lung function. Risk factors include age, genetics, and environmental/occupational factors. IPF usually occurs in adults aged older than 50 years, particularly those with a history of cigarette smoking, and affects more men than women. While a number of investigational drugs in development, only two drugs, pirfenidone and nintedanib, have US FDA approval for use in the treatment of IPF.
Bridge Biotherapeutics, Inc.