Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea and a tenant company of JLABS@TMC in Houston, Texas, announced that the Investigational New Drug (IND) application for BBT-877, a potent best-in-class drug candidate for Idiopathic Pulmonary Fibrosis (IPF), has been cleared by the US Food and Drug Administration (FDA).
Bridge Biotherapeutics now plans to initiate a Phase I study of BBT-877 in the U.S. in January 2019 to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug candidate in healthy volunteers. The planned study will be performed in two phases, a Single Ascending Dose (SAD) phase with 5 cohorts and a Multi Ascending Dose (MAD) phase with 3 cohorts. The estimated primary completion date is currently expected in late 2019.
“We are proud of the IND clearance for BBT-877, which has shown a strong potential to be developed as the best-in-class Autotaxin inhibitor for IPF treatment,” and “Our team will continue to focus on developing a breakthrough drug to address huge unmet medical needs in IPF,” stated Dr. Gwang-hee Lee, the Head of Translational Research at Bridge Biotherapeutics.
BBT-877 has been originally discovered by LegoChem Biosciences, a publicly traded Korean biotech, and was licensed to Bridge Biotherapeutics in 2017 for the worldwide exclusive right for further development. In August 2018, Bridge Biotherapeutics presented the results of the preclinical study on BBT-877 at the IPF Summit, attracting pulmonologists’ interest on the efficacy and safety of the drug candidate. The data has demonstrated the best-in-class opportunity in comparison to a current development pipeline compound.
BBT-877 is the second molecule from Bridge Biotherapeutics with the US FDA clearances of IND for proceeding clinical studies. The company is also developing BBT-401, the first anti-Pellino-1 compound for the ulcerative colitis and aims to initiate the Phase II study in the U.S. within this year.