Bridge Biotherapeutics announced that the company has presented interim data from a phase I clinical study on BBT-877, idiopathic pulmonary fibrosis (IPF) treatment candidate, at the American Thoracic Society International Conference (ATS 2019) held in Dallas, TX.
Interim pharmacokinetic and safety results of the randomized, double-blind, placebo-controlled phase I study showed that 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 severe AEs. Also, 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 Lee Gwang-hee, vice president and head of translational research at Bridge Biotherapeutics. “BBT-877 has shown potential as a best-in-class ATX inhibitor for the 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 company plans to complete the phase I study by August 2019 and will conduct a multinational phase 2 study in the U.S., Canada, Australia, and other 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 contributed to the BBT-877 safety and tolerability shown to date and supported the continued development of BBT-877 for treatment of IPF.
LegoChem Biosciences first discovered BBT-877 and licensed exclusive global rights to Bridge Biotherapeutics for further development. BBT-877 inhibits autotaxin (ATX), which is known to play a role in various diseases, including fibrosis, autoimmune disease and tumors.