SEONGNAM, South Korea and MADRID, Sept. 29, 2019 /PRNewswire/
The poster presentation of "BBT-877, a potent Autotaxin Inhibitor in Clinical Development to Treat Idiopathic Pulmonary Fibrosis" provided results of pharmacokinetic, pharmacodynamic and safety analysis from the randomized, double-blind, placebo-controlled Phase I clinical study.
During the phase I clinical study, a total of 80 healthy volunteers participated in the trials. In the SAD portion of the study, five cohorts ranging from 50mg to 800mg were administrated. For the MAD portion, dose ranging from 200mg to 800mg once daily were administrated in three cohorts and from 100mg to 200mg twice daily were dosed to two cohorts for two weeks.
The pharmacokinetic data demonstrated that the plasma concentrations, Cmax and AUC of BBT-877 have increased in a dose-proportional manner throughout the SAD and MAD portions. In addition, the data revealed a dose-proportional increase in systemic exposure with elimination half-life of 12 hours across all dose levels.
The study also confirmed that BBT-877 increasingly inhibits lysophosphatidic acid (LPA) in a dose-proportional manner based on pharmacodynamic data analysis. The decrease of plasma LPA level was maintained at 80% or higher for 24 hours when 400mg per day or higher doses of BBT-877 were administrated in the SAD portion. Additionally, the data of LPA inhibition in MAD portion suggested that 100mg twice daily and 200mg twice daily dosages showed up to 90% of LPA inhibition at a steady state.
From the aspect of safety, all dose levels of BBT-877 were well tolerated with no serious adverse events (SAEs) reported. 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.
"In addition to the non-clinical data proving the strong, competitive efficacy of BBT-877 in mouse models, this encouraging first-in-human study results demonstrated that BBT-877 is a well-tolerated drug candidate with excellent pharmacokinetic and pharmacodynamic profiles," said Gwang-hee Lee, PhD, Vice President, Head of Translational Research at Bridge Biotherapeutics. "We look forward to provide patients with IPF with new treatment option as early as possible by continuing to advance this encouraging development program with Boehringer Ingelheim."
"We are delighted about the promising results demonstrated in Phase I clinical studies conducted by our partner Bridge Biotherapeutics for BBT-887," commented Kay Tetzlaff, MD, Vice President and Medical Head of Therapeutic Area Inflammation at Boehringer Ingelheim. "This is an important step in Boehringer Ingelheim's quest to bring new breakthrough medications to patients with fibrosing interstitial lung diseases."
Along with these positive Phase I study results, Bridge Biotherapeutics has been conducting a chronic GLP toxicology study for long-term dosages. The study is expected to be finalized by the 1Q in 2020, and a multinational Phase II study of BBT-877 is planned to be initiated by mid 2020.
In July 2019, the licensing deal of BBT-877 was closed with Boehringer Ingelheim and the clinical developments beyond the Phase I study are to be led by Boehringer Ingelheim.
The original file of the poster presented at the ERS 2019 is available at: http://bridgebiorx.com/upload/pdf/ccdfcb65d90d70d43a5276385bf5bf55.pdf.
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About Bridge Biotherapeutics
Bridge Biotherapeutics Inc., based in South Korea, US and China is a clinical stage biotech company founded in 2015. Bridge Biotherapeutics is 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. BBT-401, the first-in-class Pellino-1 inhibitor for treatment of ulcerative colitis, is currently in Phase II in the US, and BBT-877, an autotaxin inhibitor to treat various fibrosing interstitial lung diseases including idiopathic pulmonary fibrosis (IPF), was licensed to Boehringer-Ingelheim for further development in July 2019 with potential license value more than 1.1 billion euro. BBT-176, a potent targeted cancer therapy for non–small cell lung cancer (NSCLC) is also in development. Bridge Biotherapeutics is a resident company of JLABS @ Shanghai.
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)
IPF is a rare, debilitating and fatal lung disease which affects approximately 3 million people worldwide. Progression of IPF is variable and unpredictable, and over time the lung function of an IPF patient gradually and irreversibly declines. To find out more about IPF, visit lifewithipf.com where you can access a range of materials.
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SOURCE Bridge Biotherapeutics, Inc.